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ICD to cancer patients, draft 4, March 3, 2013
INFORMED CONSENT DOCUMENTS PROVIDED TO CANCER
PATIENTS WHO PARTICIPATE IN CLINICAL TRIALS
Prepared by Harry Bleiberg and Genevieve Decoster
INTRODUCTION
Investigators and Ethics Committee members often are facing different methodologies and
approaches regarding the patients' informed consent documents that they should review
and approve before being used during clinical trials. The content of those documents follows
several different declarations, reports or guidelines (1-4) which are binding in some
countries. Those documents are supposed to protect the patients and to guide the set up
and the conduct of clinical research.
Informed consent documents for cancer clinical trials become too long, complicated, and
difficult to understand. It would be valuable that a comprehensive approach on the content
of informed consent document is applied in all cancer clinical trials.
INFORMED CONSENT
In clinical research, informed consent should be obtained from a patient who is able to
understand the purpose, the effects, and the consequences of the proposed research
objectives. Therefore, the participants in clinical trials must be sufficiently informed on the
purposes and requirements of a clinical trial protocol. Adequate, accurate and clear
information should encourage rather than discourage patients to contribute to cancer
research.
Informed consent documents should be developed in a lay language and must reflect the
protocol requirements, the current knowledge of the investigational product and the disease
under investigation. Trial participants must have the ability to understand the information to
make an autonomous decision on whether or not he/she would like to contribute to the
research proposed by the investigator.
BRIEF HISTORY OF INFORMED CONSENT
After World War II, it became obvious that individuals who participate in clinical research
must be informed and freely give their consent. There are five major organizations that
contributed to the development of the current process for the protection of trial participants
(1-5). Although the vast majority of the reference documents are not legally binding, they
are basically a moral obligation for investigators.
The Nurnberg Code
In 1947, the Nurnberg Code provides the basis for the international ethical standard to be
applied in medical research leading to the creation of Institutional Review Boards or
Independent Ethics Committees (1).
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The Declaration of Helsinki
In 1964, the World Medical Association (WMA) issued the Declaration of Helsinki which is
the foundation of ethical principles to be applied while performing research on human
beings. The document has been reviewed several times, the last update was published in
2008 (2).
The Belmont Report
In 1978, the Belmont Report was published by the National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research in the USA. The Belmont Report,
mainly used in the USA, has three fundamental ethical principles to be applied to perform
medical research on human beings: Respect for persons, Beneficence, and Justice. In
addition, the report emphasizes that the investigator must be sure that the patient
understands the full extent to the experiment (3).
The CIOMS Ethical Guideline
The Council for International Organizations of Medical Sciences (CIOMS) in collaboration
with the World Health Organization (WHO) produced an International Ethical Guideline for
Biomedical Research Involving Human Subjects. The guidelines reflect the principal ethical
concern for attention in protecting the rights and welfare of research participants (4).
ICH-E6- Good Clinical Practice Guideline
In 1997, the International Conference on Harmonization (ICH) developed the Good Clinical
Practice (GCP) guidelines setting up an international ethical and scientific quality standard
for the designing, conducting, recording and reporting trials that involved human beings (5).
The twenty elements to be part in the Informed Consent documents are described in section
4.8.10.
Today, global clinical research programs use ICH recommendations as THE standard to be
applied in their entire clinical research activities. ICH documents are used as "bibles" and
guide documents by health authority inspectors, clinical trial monitors, Ethics Committee
members, and clinical trial sponsors to review and approve a research program.
CONTENT OF INFORMED CONSENT DOCUMENTS
Background
For a trial participant to give a valid informed consent, the information contains in the
document(s) must be clear, unambiguous, written in lay language and understandable by the
target population. Therefore, the content of informed consent documents should be simple,
not too long, accurate and non-technical. There should be no abbreviations, jargon language
or scientific-type terminology without explanation.
Currently, the quality of the content of the informed consent documents is variable and goes
from very technical terminology to insufficient information or no information.
Attention should also be paid to those multiple Informed Consent Forms signed by a single
patient who participate to a main study and, as it is often the case in cancer, to several substudies (genomics, genetics, pharmacokinetics, etc…).
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In the USA, the National Cancer Institute (NCI), along with the Office for Protection from
Research and the U.S. Food and Drug Administration, formed an Informed Consent Working
Group to propose solutions (6). The group created an informed consent form template that
includes all of the ethical and research elements required for the document, including
explanation of the research procedures, related risks and possible benefits, alternatives to
participation, and the rights of research participants.
The template proposed below is based on the NCI version, but more appropriate for an
international use.
REFERENCES
1. Nurnberg Code: http://ori.dhhs.gov/education/products/RCRintro/c03/b1c3.html
2. Declaration of Helsinki: WMA Declaration of Helsinki Ethical principles for medical
research involving human subjects, 2008.
http://www.wma.net/en/30publications/10policies/b3/index.html.pdf?print-mediatype&footer-right=[page]/[toPage].
3. Belmont Report. Ethical Principles and Guidelines for the Protection of Human.
Subjects of Research. The National Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research (DHEW Publication No. (OS) 78-0014).
http://www.brynmawr.edu/ceo/students/ethics/belmontreport.html.
4. CIOMS Report: International Ethical Guidelines for Biomedical Research Involving
Human Subjects. CIOMS, Geneva, 2002
5. ICH-GCP E6 guidelines: International Conference on Harmonization E6 Good Clinical
Practice Consolidated Guideline Jan 1997.
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E
6_R1/Step4/E6_R1__Guideline.pdf.
6. National Cancer Institute Informed consent template.
http://www.cancer.gov/clinicaltrials/conducting/simplification-of-informed-consentdocs/page5.
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ICD to cancer patients, draft 4, March 3, 2013
TEMPLATE
PATIENT INFORMATION
INFORMED CONSENT FORM
This template is based on the NCI-ICF template. Any color text is not in the original NCI
document.



Italic Green Text helps the IC authors to complete the template
Text to be adapted to the study requirement (YYYY/MM/DD)
A glossary is available at the back of the document to be added to the IC. Only
terms used in the IC should be kept-
Protocol title: Spell out the study title and study identification code, document version
number and date.
This is a clinical research study (Adjuvant Study, neoadjuvant study, Phase I, II, III,) of a new
anticancer product. Your doctor will explain the clinical study to you. Clinical studies include
only people who choose to take part. Please take your time to make your decision about
taking part. You may discuss your decision with your family and friends. You can also discuss
it with your family doctor. If you have any questions, you can ask your study doctor for more
explanation.
You are being asked to take part in this study because you have a cancer (describe the type
and stage of the cancer such as "colon cancer that has spread and has not responded to
previous treatment)
1. Why is this study being done?
The purpose of this study is to evaluate the tolerability and the activity of a new anticancer
drug called XXX, YYY ZZZ. The drug is still experimental and is not available on the market.
The study will assess the drug define the study objectives.
The patient must understand the research objective (therapeutic benefit, equivalency, better
understanding of the disease ...)
Provide the main inclusion criteria, as they are written in the protocol
2. What is my current situation
Give the prognosis of the disease for the stage concerned by the cancer clinical trial.
• Will cancer cure be achieved?
• Would other treatment be available and effective? Give established figures (e.g. for stage
III colon cancer, at 5 years, survival is 72% and most of the patients are cured...)
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• If the disease cannot be cured give an estimation of the life expectancy, without treatment
and/or with current cancer treatments if available and / or with palliative-care program. Give
time periods established in the literature, median / mean (SD) *. Justify these numbers by one
or two electronic references
3. What are the characteristics of the proposed treatment
The following treatment is planned in this clinical trial:
• give the drug family name and whether it is a new drug, new technology. Provide
information on other drug from the same family, if any
• a simple description of the route of administration and of the mode of action,.
• What is the expected benefit?
 Give the statistical hypothesis described in the protocol and its significance in terms of
expected benefit such as the anticipated expected
4. What other choices do I have if I do not take part in this study?
Your other choices may include:
o Getting treatment or care for your cancer without being in a study
What is the expected benefit with the various options (% absolute gain in the
adjuvant setting, median survival gain (range) in the metastatic and / or % survival at
6 months or 1 year and / or disease-free survival).
o Taking part in another study
o Getting no treatment
o Getting comfort care, also called palliative care. This type of care helps reduce pain,
tiredness, appetite problems and other problems caused by the cancer. It does not
treat the cancer directly, but instead tries to improve how you feel. Comfort care
tries to keep you as active and comfortable as possible.
Explain briefly what might be available, such as palliative, or any other supportive
care.
Talk to your doctor about your choices before you decide if you will take part in this study.
5. What adverse events can I expect from being in the study?
You may experience adverse events during the treatment with the study drug. Everyone
taking part in the study will be monitored carefully for any adverse event occurrence.
However, doctors do not know all the adverse events that may happen. Adverse events may
be mild or more serious. Your study doctor may give you medicines to reduce some adverse
events. Many adverse events go away soon after you stop taking the study medication. In
some cases, adverse events can become serious, long lasting, or may never go away.
You should talk to your study doctor about any adverse events that you have while taking
part in the study.
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The following risk has been observed in human studies with this new drug: example: change
in liver function tests (test that shows how the liver is working).
The adverse events seen in animal studies and previous human studies tell your doctor what
kind of adverse events the study drug may induce. The following adverse events have been
reported:
Potential adverse events of the planned treatment:
• All known adverse events should be classified in a table by frequency order and severity
-
Specify the known rate of treatment-related death (grade 5) (indicate '0 'if there is
no known lethal toxicity)
-
Use the data of the planned drug if they are known and published or, if not
available, data from similar products. If any data is available specify that adverse
events are unknown.
• Quantify the possible durations of hospitalization, burden of toxicities (mucositis, hand-foot
syndrome, septic shock, ...) in terms of quality of life, more invasive tests ...
• Overall impact on quality of life.
Severity is defined as:
 Mild (grade1): The adverse event is noticeable but does not interfere with your
routine activity; intervention is not indicated.
 Moderate (grade 2): The adverse event interferes with your routine activity but
responds to therapy or rest.
 Severe (grade 3): The adverse event significantly limits your ability to perform daily
activities despite treatment, that may include hospitalization or prolongation of
hospitalization;
 Life-threatening (grade 4): you are at immediate risk of death. You are requiring
urgent intervention.
 Fatal (grade 5): The outcome of the adverse event is death (not death due to your
disease)
The table below lists the adverse events known with the proposed clinical trial
Type of
adverse event
Percentage
of total no.
of adverse
events
GRADE 0
GRADE 1
GRADE 2
GRADE 3
GRADE 4
GRADE 5
None
Mild
Moderate
Severe
Life-threatening
Death
%
%
%
%
%
%
To be organized by frequency order
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6. How many patients will take part in the study?
Approximately XX to XXX patients will take part in this study.
7. What will happen if I take part in this research study?
Before taking part into the study, your study doctor will ask you to perform some exams and
tests to find out whether you can be in the study. The vast majority of these exams and tests
are part of routine medical care for your disease and may be done even if you do not join the
study. If you have had some of them recently, they may not need to be repeated. This will be
up to your study doctor.
To take part in the study you will have a complete review of your medical history including
signs and symptoms, prior cancer treatments, and medications taken for the last 4-6 weeks.
Your study doctor will also ask you whether you can carry out daily activities. Physical
examination will include measurement of your weight, height, blood pressure, and pulse
rate. You will also be asked about any other symptoms you may have. Blood tests will be
taken to test your organ function, such as hematology level, biochemistry level, renal and
liver function to ensure that you can safely receive the new drug. Other tests might be
performed such as an electrocardiogram to measure your heart rhythm, if your study doctor
thinks it is your best interest. Some radiography and other imaging techniques, such as CT
scans, MRI scans, bone scans, or PET scans, might be performed to evaluate the size of your
tumor.
If you are a female of childbearing potential, a blood pregnancy test (-HCG) must be done
and must be negative before receiving the study medication.
8. During the study
If the examinations and tests show that you can be in the study, and you choose to take part,
then during your participation in the study, you will need to go to the hospital regularly to
receive the study medication, have blood tests, be examined and your doctor will evaluate
how you tolerate the study drug. Some exams and tests that are performed before you
decided to participate in the study might be repeated during the study. A table below
describes in detail the schedule of your hospital visits, the exams and tests to be performed.
You will receive the study medication every week for 2 out of 3 weeks, meaning on day 1 and
8 of a 21-day course (also called cycle). From day 9 until day 21 of every course, you will have
a rest period. You will receive a total of four courses, unless your doctor thinks it is in your
best interest to stop the study medication before the end of the four courses or if you decide
to withdraw from the study. The duration of the entire therapy is 12 weeks.
To be adapted to the study protocol requirements
In addition to the normal examinations and tests performed for your disease, your study
doctor will ask you to collect blood samples on day 1 of the first and second course. There
will be 8 blood samplings over a period of 24 hours on the first days the drug is administered
in the first two courses of treatment. The total quantity of blood sampling for 16 blood
samples will be 64 mL. The purpose of taking these blood samples is to evaluate how the
drug circulates in your body and how your body eliminates the drug.
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An additional 10 mL of blood will also be collected to check for specific enzymes in your body
that might help the physicians better understand which patients best would benefit from the
study medication in the future (this is also referred to as pharmacogenetics testing).
Biopsies to obtain tissue and blood samples for the pharmacodynamics evaluation will only
be taken at the higher dose of the study. Ask your study doctor whether you will participate
in this part of the study. If so, you will have to consent that this can be done and a full
description will be given to you at the end of this document.
To be adapted to the study protocol
9. When I am finished taking the study drug
A follow-up visit will be performed 4 weeks after the last drug administration and what you
need to do is described in the table below.
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10.Summary of events before and during treatment
The be adapted to the study protocol
Visit Day
One week
before
starting
the study
Exams, tests and other procedures







Course 1
Day 1

You may be asked to have a biopsy of your cancer tissue and a blood sample to
look for circulating tumor cells

Blood sample for pharmacogenetics



Review of your signs and symptoms and current medications
Ability to perform activities of daily living (performance status) will be evaluated
Physical examination including measurement of your weight, blood pressure, and
pulse rate.
Blood tests (approximately 30mL) will be drawn to evaluate your hematology, your
blood chemistry, your kidney and liver function to ensure that you can safely
receive the study drug
The drug will be infused/administered through your veins over 3 hours
Blood tests for pharmacokinetic study (approximately 4mL each sample) of blood
drawn over a period of 8 hours in the clinic and one blood sampling the next day
24 hours after you have received the medication
Blood tests for pharmacodynamic




Course 1


Day 8
Course 1
Day 15
Complete review of your medical history including signs and symptoms, prior
treatments, and medications taken the last 4-6 weeks
Ability to perform your daily activities, also called your performance status ,will be
evaluated
Physical examination includes measurement of your weight, height, blood pressure,
and pulse rate. You doctor will also ask whether you have any other complaints
Blood tests (approximately 30mL) will be drawn to evaluate your hematology, your
blood chemistry, your kidney and liver function to ensure that you can safely
receive the study drug
You may have an electrocardiogram to measure your heart rhythm (if necessary)
Radiography or other imaging systems will be done to measure the size of your
tumor (for example, CT scans, MRI scans, bone scans, PET scans)
Blood pregnancy test (B-HCG) if you are a female of childbearing potential




Review of your signs and symptoms and current medications
Blood tests (approximately 30 mL) will be drawn to evaluate your hematology,
your blood chemistry, your renal and liver function to ensure that you can safely
receive the study medication
Evaluation of any adverse event you experienced from the study drug
Ability to perform activities of daily living (performance status) will be evaluated
The study drug will be infused/administered through your veins over 3 hours
Study visit is not mandatory. However, your doctor may request to see you in
clinic.
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ICD to cancer patients, draft 4, March 3, 2013
Visit Day
Exams, tests and other procedures
Course 2

Day 1
Ability to perform your daily activities , also called your performance status ,will
be evaluated

Review of your signs and symptoms and your current medication

Physical examination includes measurement of your weight, blood pressure, and
pulse rate. You doctor will also ask whether you have any eye complaints and will
assess your lung functioning

Blood tests (approximately 30mL) will be drawn to evaluate your hematology, your
blood chemistry, your kidney and liver function to ensure that you can safely
receive the study drug

Evaluation of any adverse event you experienced from the previous administration
of the study drug

The study drug will be infused/administered through your veins over 3 hours

Blood tests for pharmacokinetic study (approximately 4mL each sample) of blood
drawn over a period of 8 hours in the clinic and one blood sampling the next day
24 hours after you have received the medication

You may be asked to have a biopsy of your cancer tissue and a blood sample to
look for circulating tumor cells

Review of your signs and symptoms and your current medication

Blood tests (approximately 30mL) will be drawn to evaluate your hematology, your
blood chemistry, your kidney and liver function to ensure that you can safely
receive the study drug

Evaluation of any adverse event you experienced from the previous administration
of the study drug

Ability to perform activities of daily living (performance status) will be evaluated

The drug will be infused through your veins over 3 hours

Study visit is not mandatory. However, your doctor may request to see you in
clinic.

Radiography or other imaging systems will be done to measure the size of your
tumor (for example, CT scans, MRI scans, bone scans, PET scans)
Course 2
Day 8
Course 2
Day 15
Every
Cycles
Other
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11.Can I stop being in the study?
Yes. You can decide to stop at any time. Tell your study doctor if you are thinking about
stopping or decide to stop. He or she will tell you how to stop safely. If you decide to stop
taking the study medication, the study doctor will discuss with you what needs to be done
and what alternative treatment you can receive.
The study doctor may stop you from taking part in this study at any time if he/she believes it
is in your best interest; or if you do not come regularly to the hospital to perform the tests
and examinations required by the study; or if the study is prematurely discontinued.
12.Reproductive risks
You should not become pregnant (or father a baby) while on this study because the drugs in
this study can affect an unborn baby. Women should not breastfeed a baby while on this
study. It is important you understand that you need to use birth control while on this study.
Check with your study doctor about what kind of birth control methods to use and how long
to use them. Blood pregnancy testing will be done before you receive the first dose of the
new treatment.
13.Are there benefits to taking part in the study?
Taking part in this study may or may not make your health better. While doctors hope that
the study drug will be more useful against cancer compared to the usual treatment, there is
no proof of this yet. We do know that the information from this study will help doctors learn
more about the study drug as a treatment for cancer. This information could help future
cancer patients.
14.Will my medical information be kept private?
All your information and medical records are kept private that means that no one can trace
the results back to you. Only your study doctor will be able to link up the findings with the
other information about you. All your personal data (names, address, for instance) will be
kept at the hospital and will never be transferred to the Sponsor or be published.
On the other hand, you must be aware and agree that personal information may be checked
during the course of the study by a clinical trial monitor or an auditor appointed by the
Sponsor and inspected by Health Authority representatives. All staff involved in this clinical
trial, or Health Authority representatives will treat your personal information as strictly
confidential and will not make them publicly available.
An Independent Ethics Committee has approved on DD/MMM/YYYY this clinical research
program before the first patient was asked to participate.
15.What are the costs of taking part in this study?
Taking part in this study is free of charge. The Sponsor will provide your study doctor with
enough study medication for your participation in the study.
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If you experience a serious adverse reaction due to the administration of the study drug or
due to the procedures required by the study, all treatments and/or hospitalization (if
required) will be charged to the Sponsor.
Treatments for other diseases or signs and symptoms you had before participating in the
study or occurring during the study, but being not related to the study drug or the study
procedure will be charged to your health insurance or yourself.
On the other hand, you will not be paid for taking part in this study.
16.What happens if I am injured because I took part in this study?
You need to know that, in case you are injured during the course of the study, the Sponsor
has taken an insurance covering the claims of a patient in case of a study-related unexpected
serious adverse reaction(s).
It is important that you immediately tell your study doctor, Dr. ________ , if you feel that
you have been injured because of taking part in this study.
17.What are my rights if I take part in this study?
Taking part in this study is your choice. You may choose either to take part or not to take
part in the study. If you decide to take part in this study, you may leave the study at any
time. No matter what decision you make, there will be no penalty to you and you will not
lose any of your regular benefits. Leaving the study will not affect your medical care. You can
still get your medical care from our institution.
We will tell you about new information or changes in the study that may affect your health
or your willingness to continue in the study.
In the case of injury resulting from this study, you do not lose any of your legal rights to seek
payment by signing this form.
18.Who can answer my questions about the study?
You can talk to your study doctor about any questions or concerns you have about this
study. Contact your study doctor, Dr. _______ at ______________.
You can get more information about the conduct of this study or the rights of research
participants from the Ethics Committee responsible for this site. To contact the Ethics
Committee please call _______ at ______________.
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Please note:
This section of the informed consent form is about additional research studies that are
being done with people who are taking part in the main study. You may take part in these
additional studies if you want to. You can still be a part of the main study even if you say
'no' to take part in any of these additional research studies.
You can say "yes" or "no" to each of the following studies.
Please mark your choice for each study.
INFORMATION FOR USE OF TISSUE SAMPLES FOR ADDITIONAL RESEARCH
About Using Tissue Samples for Additional Research
You are going to have a biopsy (or surgery) to see if you have cancer. Your doctor will
remove some body tissue and blood sample to do some tests. The results of these tests will
be given to you by your doctor and will be used to plan your care.
We would like to keep some of the tissue that is left over for future research. If you agree,
this tissue will be kept and may be used in research to learn more about cancer and other
diseases. Please read the information sheet called "How is Tissue Used for Research” and
learn more about tissue research.
Your tissue may be helpful for research whether you do or do not have cancer. The research
that may be done with your tissue is not designed specifically to help you. It might help
people who have cancer and other diseases in the future.
Reports about research done with your tissue will not be given to you or your doctor. These
reports will not be put in your health record. The research will not have an effect on your
care.
Things to Think About
The choice to let us keep the left over tissue for future research is up to you. No matter what
you decide to do, it will not affect your care.
If you decide now that your tissue can be kept for research, you can change your mind at any
time. Just contact us and let us know that you do not want us to use your tissue. Then any
tissue that remains will no longer be used for research and will be destroyed.
In the future, people who do research may need to know more about your health. While
they may be given those reports about your health, your personal information will not be
disclosed (your name, address, phone number, or any other information that will let the
researchers know who you are).
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Sometimes tissue is used for genetic research (about diseases that are passed on in
families). Even if your tissue is used for this kind of research, the results will not be put in
your health records.
Your tissue will be used only for research and will not be sold. The research done with your
tissue may help to develop new treatment in the future.
Benefits
The benefits of research using tissue include learning more about what causes cancer and
other diseases, how to prevent them, and how to treat them, especially which patients
might best potentially benefit from this study medication.
Risks
The main potential risks of having biopsies done are bleeding and infection. We also ensure
that your personal information will be kept private and confidential, according to the law on
the protection of individuals with regard to the processing of personal data and on the free
movement of such data.
INFORMED CONSENT SIGNATURES
I have been given a copy of all xx pages of this form. I have read it or it has been read to me.
I understand the information and have had my questions answered.
I agree to take part in the main study.
Yes
No
The use of my tissue samples:
I have been informed on the use of tissue samples for additional research; my decision will
not affect my care and my participation in the main study.
1. My tissue may be kept for use in research to learn about, prevent, or treat cancer.
Yes
No
2. My tissue may be kept for use in research to learn about, prevent or treat other health
problems (for example: diabetes, Alzheimer's disease, obesity or heart disease).
Yes
No
3. Someone may contact me in the future to ask me to take part in more research.
Yes
No
Patient: (print name and signature)
Date
Investigator (print name and signature)
Date
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GLOSSARY
Keep only the terminology used in the Informed Consent Documents
A
Acquired immune deficiency syndrome (AIDS): A viral disease that destroys the body's
ability to fight infections, leaving the body susceptible to many other diseases.
Acute: A sudden onset of symptoms or disease.
Adenocarcinoma : See Carcinoma.
Adenoma: A benign tumor made up of glandular tissue. For example, an adenoma of the
pituitary gland may cause it to produce abnormal amounts of hormones.
Adjuvant chemotherapy: Chemotherapy given to kill any remaining cancer cells, usually
after all detectable tumor is removed by surgery or radiotherapy.
Adrenal glands: Two small organs near the kidneys that release hormones.
Adverse event, adverse effect (side effect): Any unfavorable and unintended sign (including
an abnormal laboratory finding), symptom, or disease temporally associated with the
use of a medicinal product, whether or not related to the medicinal product
AFP (Alpha fetoprotein): A tumor marker.
Alopecia: The loss of hair, which may include all body hair as well as scalp hair.
Analgesic: Any drug that relieves pain. Aspirin and acetaminophen are mild analgesics.
Anemia: A condition in which a decreased number of red blood cells may cause symptoms
including tiredness, shortness of breath, and weakness.
Angiogenesis: The physiological process through which new blood vessels form from preexisting vessels. Tumors induce blood vessel growth (angiogenesis) by secreting
various growth factors.
Anorexia: The loss of appetite.
Antibody: A substance formed by the body to help defend it against infection.
Antiemetic agent: A drug that prevents or controls nausea and vomiting.
Antifungal agent: A drug used to treat fungal infections.
Antigen: Any substance that causes the body to produce natural antibodies.
Antineoplastic agent: A drug that prevents, kills, or blocks the growth and spread of cancer
cells.
Arrhythmia: An irregular heartbeat.
Aspiration: The process of removing fluid or tissue, or both, from a specific area.
Autoimmunity: Conditions in which the body's immune system mistakenly fights and rejects
the body's own tissues.
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Axilla: The armpit.
Axillary nodes: Lymph nodes - also called lymph glands found in the armpit (axilla).
B
Barium enema: The use of a milky solution (barium sulfate) given by an enema to allow x-ray
examination of the lower intestinal tract.
Barium swallow: The use of a milky solution (barium sulfate) given orally to allow x-ray
examination of the upper intestinal tract.
Benign growth: A swelling or growth that is not cancerous and does not spread from one
part of the body to another.
Biopsy: The surgical removal of tissue for microscopic examination to aid in diagnosis.
Blood cells: Minute structures produced in the bone marrow; they consist of red blood cells,
white blood cells, and platelets.
Blood count: The number of red blood cells, white blood cells, and platelets in a sample of
blood.
Bone marrow: The spongy material found inside the bones. Most blood cells are made in the
bone marrow.
Bone marrow biopsy and aspiration: The procedure by which a needle is inserted into a
bone to withdraw a sample of bone marrow.
Bone marrow suppression: A decrease in the production of blood cells.
Bone marrow transplant: The infusion of bone marrow into a patient who has been treated
with high dose chemotherapy or radiation therapy. Patients may use their own
marrow, which in some cases has been frozen.
Allogeneic: The infusion of bone marrow from one individual (donor) to another.
Autologous: The infusion of a patient's own bone marrow previously removed and
stored.
Syngeneic: The infusion of bone marrow from one identical twin into another.
Bone scan: A picture of the bones using a radioactive dye that shows any injury, disease, or
healing. This is a valuable test to determine if cancer has spread to the bone, if
anticancer therapy has been successful, and if affected bony areas are healing.
Breast self-examination (BSE): A manual self-examination of the breasts.
Bronchoscopy: The insertion of a flexible, lighted tube through the mouth into the lungs to
examine the lungs and airways.
C
Cancer: A group of diseases in which malignant cells grow out of control and spread to other
parts of the body.
Cancer in situ: The stage where the cancer is still confined to the tissue in which it started.
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Candidiasis: A common fungal infection.
Carcinogen: A substance that causes cancer. For example, nicotine in cigarettes is a
carcinogen that causes lung cancer.
Carcinoma: A type of cancer that starts in the skin or the lining of organs.
Adenocarcinoma: A malignant tumor arising from glandular tissue.
Basal cell carcinoma: The most common type of skin cancer.
Bronchogenic carcinoma: A cancer originating in the lungs or airways.
Cervical carcinoma: A cancer of the cervix (the neck of the uterus).
Endometrial carcinoma: A cancer of the lining of the uterus.
Squamous cell carcinoma: Cancer arising from the skin or the surfaces of other
structures, such as the mouth, cervix, or lungs.
Cardiomegaly: An enlargement of the heart.
CAT scan (CT scan): A test using computers and x-rays to create images of various parts of
the body.
CEA (Carcinoembryonic antigen): A blood tumor marker.
Cellulitis: The inflammation of an area of the skin (epithelial layer).
Central venous catheter: A special intravenous tubing that is surgically inserted into a large
vein near the heart and exits from the chest or abdomen. The catheter allows
medications, fluids, or blood products to be given and blood samples to be taken.
(Examples of types of central venous catheters are Broviac, Groshong, Hickman, etc.)
Cervical nodes: Lymph nodes in the neck.
Chemotherapy: The treatment of cancer with drugs.
Adjuvant chemotherapy: Chemotherapy given to kill any remaining cancer cells,
usually after all detectable tumor is removed by surgery or radiotherapy.
Combination chemotherapy: The use of more than one medicinal product during
cancer treatment.
Neoadjuvant chemotherapy: The administration of chemotherapy before a main
treatment, aiming to reduce the size or extent of the cancer before using radical
treatment intervention.
Chondrosarcoma: A malignant tumor of cartilage that usually occurs near the ends of the
long bones.
Chronic: Persisting over a long period of time.
Colonoscopy: A procedure to look at the colon or large bowel through a lighted, flexible
tube.
Colony-stimulating factor (CSF): An injectable substance used to stimulate the bone marrow
to produce more cells.
Colostomy: A surgical procedure by which an opening is created between the colon and the
outside of the abdomen to allow stool to be emptied into a collection bag.
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Colposcopy: Examination of the vagina and cervix with an instrument called a colposcope.
Congestive heart failure: A buildup of fluid in the lungs or extremities, or both (especially
the legs). This occurs if the heart cannot pump the blood adequately.
Cyst: An accumulation of fluid or semisolid material within a sac.
Cystitis: An inflammation of the bladder.
Cytostatic: Capable of stopping cells dividing
Cytotoxic: Capable of killing cells
D
Drug resistance: The result of cells' ability to resist the effects of a specific drug.
Dysphagia: Difficulty in swallowing.
Dyspnea: Difficult or painful breathing; shortness of breath.
Dysuria: Difficult or painful urination.
E
Edema: The accumulation of fluid in part of the body.
Effusion: A collection of fluid in a body cavity, usually between two adjoining tissues. For
example, a pleural effusion is the collection of fluid between two layers of the pleura
(the lung's covering).
Electrocardiogram (EKG or ECG): A test that takes recordings of the electrical activity of the
heart.
Endoscopy: A procedure looking at the inside of body cavities, such as the esophagus (food
pipe) or stomach.
Erythema: Redness of the skin.
Erythrocyte: The red blood cell that carries oxygen to body cells and carbon dioxide away
from body cells.
Esophagitis: Inflammation of the esophagus (food pipe).
Estrogen: A female hormone produced primarily by the ovaries.
Estrogen receptor assay (ER assay): A test that determines if breast cancer is stimulated by
the hormone estrogen.
Excision: Surgical removal.
Extravasation: The leaking of intravenous fluids or medications into tissue surrounding the
infusion site. Extravasation may cause tissue damage.
F
Fine-needle aspirate: A procedure in which a needle is inserted, under local anesthesia, to
obtain a sample for the evaluation of suspicious tissue.
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Fistula: An abnormal opening between two areas of the body.
Frozen section: A technique in which tissue is removed and then quick-frozen and examined
under a microscope by a pathologist.
G
Granulocyte: A type of white blood cell that kills bacteria.
Groshong catheter: See Central venous catheter.
Guaiac test: A test that checks for hidden blood in the stool.
H
Hematocrit (Hct): The percentage of red blood cells in the blood. A low hematocrit
measurement indicates anemia.
Hematologist: A doctor who specializes in the problems of blood and bone marrow.
Hematology: The science that studies the blood.
Hematuria: Blood in the urine.
Hemoccult (Guaiac) test: A test that checks for hidden blood in the stool.
Herpes simplex: The most common virus that causes sores often seen around the mouth,
commonly called cold sores.
Herpes zoster: A virus that settles around certain nerves causing blisters, swelling, and pain.
This condition is also called shingles.
Hickman catheter: A special intravenous tubing that is surgically inserted into a large vein
near the heart. See central venous catheter.
Hodgkin's disease: A cancer that affects the lymph nodes. See Lymphoma.
Hormones: Substances secreted by various organs of the body that regulate growth,
metabolism, and reproduction.
Hospice: A concept of supportive care to meet the special needs of patients and family
during the terminal stages of illness. The care may be delivered in the home or hospital
by a specially trained team of professionals.
Human immunodeficiency virus (HIV): The virus that causes AIDS.
Human leukocyte antigen test (HLA): A special blood test used to match a blood or bone
marrow donor to a recipient for transfusion or transplant.
Hyperalimentation: The intravenous administration of a highly nutritious solution.
I
Ileostomy: A surgical opening in the abdomen connected to the small intestine to allow stool
to be emptied into a collection bag.
Immunity (Immune system): The body's ability to fight infection and disease.
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Immunosuppression: Weakening of the immune system that causes a lowered ability to
fight infection and disease.
Immunotherapy: The artificial stimulation of the body's immune system to treat or fight
disease.
Infiltration: The leaking of fluid or medicines into tissues, which can cause swelling.
Infusion: Delivering fluids or medications into the bloodstream over a period of time.
Infusion pump: A device that delivers measured amounts of fluids or medications into the
bloodstream over a period of time.
Injection: Pushing a medication into the body with the use of a syringe and needle.
Intramuscular (IM) injection: Injection into the muscle.
Intravenous (IV) injection: Injection into the vein.
Subcutaneous injection: Injection into the fatty tissue under the skin.
Interferon: A naturally produced chemical released by the body in response to viral
infections. Interferon can be artificially produced and used as a form of
immunotherapy.
Interleukin: A naturally produced chemical released by the body.
L
Laryngectomy: The surgical removal of the larynx.
Lesion: A lump or abscess that may be caused by injury or disease, such as cancer.
Leukemia: Cancer of the blood. White blood cells may be produced in excessive amounts
and are unable to work properly.
Leukocyte: See also White Blood Cell (WBC). General term for a variety of cells responsible
for fighting invading germs, infection, and allergy-causing agents. Specific white blood
cells include granulocytes and lymphocytes.
Leukopenia: A low number of white blood cells.
Lumpectomy: See Mastectomy-Segmental.
Lymphangiogram: A test to look at the lymph nodes.
Lymphatic system: A network that includes lymph nodes, lymph, and lymph vessels that
serves as a filtering system for the blood.
Lymphedema: Swelling either from obstructed cancerous lymph nodes or from surgically
removed lymph nodes.
Lymph nodes: Hundreds of small oval bodies that contain lymph. Lymph nodes act as our
first line of defense against infections and cancer.
Lymphocytes: White blood cells that kill viruses and defend against the invasion of foreign
material.
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Lymphoma: A cancer of the lymphatic system. Doctors differentiate the different
lymphomas by the type of cell that is involved in the makeup of the tumor. Treatments
depend on the type of cell that is seen.
M
Malignant tumor: A tumor made up of cancer cells of the type that can spread to other parts
of the body.
Mammogram (Mammography): A low-dose x-ray / picture of the breasts to determine
whether abnormal growths or cysts are present.
Mastectomy: The surgical removal of the breast.
Mastectomy - Segmental (lumpectomy): Removal of the lump and a small amount of
surrounding breast tissue.
Mastectomy - Simple (modified mastectomy): Removal of the entire breast.
Mastectomy - Radical: Removal of the entire breast along with underlying muscle and
lymph nodes of the armpit.
Median: In statistics, median is described as the numerical value separating the higher half
of a sample (such as a population) from the lower half.
Melanoma: A cancer of the pigment-forming cells of the skin or the retina of the eye.
Metastasis: To spread from the first cancer site, for example, breast cancer that spreads to
the bone.
Monoclonal antibodies: Artificially manufactured antibodies specifically designed to find
targets on cancer cells for diagnostic or treatment purposes.
MRI (Magnetic resonance imaging): A sophisticated test that provides in-depth images of
organs and structures in the body.
Mucosa (Mucous membranes): The lining of the mouth and gastrointestinal tract.
Mucositis: Inflammation of the lining of the mouth or gastrointestinal tract.
Myelogram: An x-ray procedure by which a dye is injected into the spinal column to show
any pathology of the spinal cord.
Myeloma: A malignant tumor of the bone marrow associated with the production of
abnormal proteins.
Myelosuppression: A decrease in the production of red blood cells, platelets, and some
white blood cells by the bone marrow.
N
Neoplasm: A new growth of tissue or cells; a tumor that is generally malignant.
Neoadjuvant chemotherapy: The administration of chemotherapy before a main treatment,
aiming to reduce the size or extent of the cancer before using radical treatment
intervention.
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Neutropenia: A decreased number of neutrophils, a type of white blood cell.
Non-Hodgkin's lymphoma: A cancer of the lymphatic system. Non-Hodgkin's lymphoma is
related to Hodgkin's disease but is made up of different cell types. See Lymphoma.
O
Oncologist: A doctor who specializes in oncology.
Oncology: The study and treatment of cancer. Doctors who specialize in oncology are called
oncologists.
P
Palliative treatment: Treatment aimed at the relief of pain and symptoms of disease but not
intended to cure the disease.
Pap (Papanicolaou) smear: A test to detect cancer of the cervix.
Paracentesis: Removing fluid from the abdomen using local anesthesia and needle and
syringe.
Pathological fracture: A break in a bone usually caused by cancer or some disease condition.
Pathology: The study of disease by the examination of tissues and body fluids under the
microscope. A doctor who specializes in pathology is called a pathologist.
Petechiae: Tiny areas of bleeding under the skin, usually caused by a low platelet count.
Phase I: Phase I trials are the first stage of testing in human beings. In cancer, a small group
of 20–100 is recruited. Phase I trials also normally include dose ranging or dose
escalation trials, so that the best and safest dose can be found and to discover the
point at which a medicinal product is too poisonous to administer
Phase II: Once a dose or range of doses is determined, the next goal is to evaluate whether
the medicinal product has any biological activity or effect. Some Phase II trials are
designed as evaluating a drug's safety and activity in a selected group of patients.
Other Phase II trials are designed as randomized clinical trials, where some patients
receive the medicinal product and others receive standard active treatment. Placebo
can be introduced in some designs, especially when combination of several medicinal
products is used.
Phase III: It is generally designed to assess the effectiveness of the new treatment and
thereby, its value in clinical practice. Phase III studies are randomized controlled on
large patient groups (300–3,000 patients) and are aimed at being the definitive
assessment of how effective the medicinal product is, in comparison with current
standard treatment
Phlebitis: A painful inflammation of the veins.
Photosensitivity: Extreme sensitivity to the sun, leaving the patient prone to sunburns. This
can be a side effect of some cancer drugs and radiation.
Placebo: An inert substance often used in clinical trials for comparison.
Platelet (Plt): Blood cells that are responsible for clotting.
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Platelet count: The number of platelets in a blood sample.
Polyp: A growth of tissue protruding into a body cavity, such as a nasal or rectal polyp.
Polyps may be benign or malignant.
Port - Implanted: A catheter connected to a quarter-sized disc that is surgically placed just
below the skin in the chest or abdomen. The tube is inserted into a large vein or artery
directly into the bloodstream. Fluids, drugs, or blood products can be infused, and
blood can be drawn through a needle that is stuck into the disc. Examples: Port-o-cath,
Infusaport, Lifeport.
Port - Peritoneal: A catheter connected to a quarter-sized disc that is surgically placed in the
abdomen. The catheter is inserted to deliver chemotherapy to the peritoneum
(abdominal cavity).
Primary tumor: The original cancer site. For example, breast cancer that has spread to the
bone is still called breast cancer.
Progesterone: One of the female hormones produced by the ovaries.
Progesterone-receptor assay: A test that determines if breast cancer is stimulated by the
hormone progesterone.
Prognosis: The projected outcome of a disease; the life expectancy.
PSA (Prostate-specific antigen)
A marker used to determine prostate disease; it may be benign or malignant.
Prosthesis: Artificial replacement of a missing body part.
Protocol: A treatment plan.
R
Radiation therapy or radiotherapy: X-ray treatment that damages or kills cancer cells.
Radiologist: A doctor who specializes in the use of x-rays to diagnose and treat disease.
Randomized clinical trial: In randomized clinical trials the patients, after assessment of
eligibility and recruitment, but before treatment begins, are randomly allocated to
receive one or other of the alternative treatments under study.
Range: The difference between the highest and the lowest values in a set
Recurrence: The reappearance of a disease after a period of remission.
Red blood cells (Erythrocytes): Cells in the blood that deliver oxygen to tissues and take
carbon dioxide from them.
Red blood count (RBC): The number of red blood cells seen in a blood sample.
Regression: The shrinkage of cancer growth.
Relapse: The reappearance of a disease after its apparent cessation.
Remission: Complete or partial disappearance of the signs and symptoms of disease.
Risk factor: Anything that increases a person's chances of developing cancer, for example,
smoking and lung cancer.
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S
Sarcoma: A malignant tumor of muscles or connective tissue such as bone and cartilage.
Chondrosarcoma: A malignant tumor of cartilage that usually occurs near the ends of
the long bones.
Ewing's sarcoma: A malignant tumor starting in bone, affecting the bones of
extremities. It often appears before the age of 20.
Shingles: See Herpes zoster.
Side effects (see adverse event): Any unfavorable and unintended sign (including an
abnormal laboratory finding), symptom, or disease temporally associated with the use
of a medicinal product, whether or not related to the medicinal product
Sigmoidoscopy: The visual examination of the rectum and lower colon using a tubular
instrument called a sigmoidoscope.
Sputum: Secretions produced by the lungs.
Staging: Determination of extent of the cancer in the body.
Statistical significance: Statistical assessment of whether observations reflect a pattern
rather than just chance.
Steroids: A type of hormone.
Stoma: An artificial opening between two cavities or between a cavity and the surface of the
body.
Stomatitis: Temporary inflammation and soreness of the mouth.
Systemic disease: A disease that affects the entire body instead of a specific organ.
T
Taste alteration: A temporary change in taste perception.
Testicular self-examination (TSE): A simple manual self-examination of the testes.
Thoracentesis (Pleural tap): A procedure to remove fluids from the area between the two
layers (pleura) covering the lung.
Thrombocytopenia: An abnormally low number of platelets (thrombocytes). If the platelet
count is too low, bleeding could occur.
Tracheostomy: A surgical opening through the trachea in the neck to provide an artifical
airway.
Tumor: An abnormal overgrowth of cells. Tumors can be either benign or malignant.
U
Ultrasound examination: The use of high frequency sound waves to aid in diagnosis.
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Unexpected serious adverse reaction: An adverse reaction, the nature or severity of which
is not consistent with the applicable product information (e.g. investigator's brochure
for an unauthorized investigational product or summary of product characteristics for
an authorized product).
Ureterostomy: A surgical procedure consisting of cutting the ureters from the bladder and
connecting them to an opening (see Stoma) on the abdomen, allowing urine to flow
into a collection bag.
V
Venipuncture: Puncturing a vein in order to obtain blood samples, to start an intravenous
drip, or to give medication.
Vesicant: A medication or agent that may cause blistering.
Virus: A tiny infectious agent that is smaller than bacteria. The common cold is caused by a
virus, and the herpes simplex virus causes cold sores.
W
White blood cells (WBC): General term for a variety of cells responsible for fighting invading
germs, infection, and allergy-causing agents. Specific white blood cells include
granulocytes and lymphocytes.
White blood cell count (WBC): The actual number of white blood cells seen in a blood
sample.
X
X-ray: High-energy electromagnetic radiation used to diagnose and treat disease. Diagnostic
test using high energy to visualize internal body organs. See Radiation therapy
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