Download CTSU N0577 screening consent (2-25-11)

IRB Approval _______________
Version Date: 2/25/11; Amendment #3
Broadcast: 3/8/11
CTSU N0577
Southeast Cancer Control Consortium Consent Form
SCREENING CONSENT FOR 1P/19Q DELETION STATUS
Note: For use by sites accruing to both NCCTG N0577 and EORTC 2605322054/RTOG 0834
Screening consent to obtain tissue samples for determination of eligibility for
studies
 N0577, Phase III Intergroup Study of Radiotherapy versus Temozolomide alone
versus Radiotherapy with Concomitant and Adjuvant Temozolomide for Patients
with Newly Diagnosed Anaplastic Oligodendroglioma or Anaplastic Mixed Glioma
with chromosomal co-deletions of 1p and 19q OR
 EORTC 26053-22054/RTOG 0834, Phase III Trial on Concurrent and Adjuvant
Temozolomide Chemotherapy in Non-1p/19q Deleted Anaplastic Glioma, the
CATNON Intergroup Trial
This is an important form. Please read it carefully. It tells you what you need to
know about this research study. If you agree to take part in this study, you need
to sign this form. Your signature means that you have been told about the study
and what the risks are. Your signature on this form also means that you want to
take part in this study.
What is a research study?
This form is being given to you to see if you would like to be part of one of the two
clinical trials listed above. The trials are a type of research study. Your study doctor will
explain the clinical trials to you. Clinical trials 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 friends and family. You can also discuss it with your health care
team. If you have any questions, you can ask your study doctor for more explanation.
You are being asked to take part in a research study because you have newly
diagnosed anaplastic oligodendroglioma or anaplastic mixed glioma.
Why is this research study being done?
The purpose of this screening is to see which one of two research studies that will be
done for the treatment of newly diagnosed anaplastic oligodendroglioma or anaplastic
mixed glioma you are eligible for. These two studies are being done to see if
temozolomide and radiation therapy together followed by temozolomide alone is better
than radiation therapy alone.
How many people will take part in the research study?
About 1,367 people will take part in these studies. This is the total number of patients
for both studies.
What will happen if I take part in this research study?
Two studies have been developed to treat people with anaplastic oligodendroglioma or
anaplastic mixed glioma. One is being run by the North Central Cancer Treatment
2/25/11
Page 1 of 5
Participant Initials _____
IRB Approval _______________
Version Date: 2/25/11; Amendment #3
Broadcast: 3/8/11
CTSU N0577
Southeast Cancer Control Consortium Consent Form
SCREENING CONSENT FOR 1P/19Q DELETION STATUS
Group (NCCTG) and the other is being run by the European Organization for Research
and Treatment of Cancer (EORTC) with the Radiation Therapy Oncology Group
(RTOG) acting as the lead group for North American participants. In order to see which
study would be best for the treatment of your disease, the investigators need to
evaluate some tumor markers. These tumor markers will tell the investigators which
study is best suited for the treatment of your disease. Once the study has been
identified, you will be told the details of the treatment and you will be given another
consent form to sign.
You have recently had a biopsy (or surgery) to see if you had cancer. Your doctor
removed some body tissue at that time. The investigators will use some of this left over
tissue to evaluate tumor markers – no additional biopsies will be done. The specific
tumor marker that will be tested to determine if you are eligible for one study or the
other is called 1p/19q. If it is decided that you are eligible for the EORTC 2605322054/RTOG 0834 study then an additional tumor marker will be tested called MGMT.
In order for these two tests to be done some of your tissue will be sent to outside
laboratories which are contracted by NCCTG and/or RTOG to do these specific tests.
The investigators will also look at slides made from your biopsy tissue that will be sent
to laboratories associated with the North Central Cancer Treatment Group (NCCTG) for
central review to confirm the results of your local laboratory review regarding your
diagnosis. This review is mandatory. These slides will be kept by the North Central
Cancer Treatment or the Radiation Therapy Oncology Group for storage depending on
which study you are eligible for. No further testing will be done on these slides.
Before you begin the study, you will also be seen by a Radiation Oncologist to be sure
that this study is the right treatment for your tumor.
Can I stop being in the research study?
Yes. You can decide to stop at any time. Tell the study doctor if you are thinking about
stopping or decide to stop. He or she will tell you how to stop safely.
It is important to tell the study doctor if you are thinking about stopping. Another reason
to tell your doctor that you are thinking about stopping is to discuss what followup care
and testing could be most helpful for you.
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; if you do not follow the study rules; or if the study is
stopped.
What side effects or risks can I expect from being in the research study?
There are no risks to you in giving us your tissue sample. No additional biopsies will be
done.
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Page 2 of 5
Participant Initials _____
IRB Approval _______________
Version Date: 2/25/11; Amendment #3
Broadcast: 3/8/11
CTSU N0577
Southeast Cancer Control Consortium Consent Form
SCREENING CONSENT FOR 1P/19Q DELETION STATUS
Will I benefit from taking part in the research study?
Taking part in this study may or may not make your health better. While doctors hope
the study you are registered on 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 agents as a treatment for cancer. This
information could help future cancer patients.
What other choices do I have if I do not take part in this research study?
You do not have to be in this study to receive treatment for your cancer.
Your other choices may include:
 Getting treatment or care for your cancer without being in a study
 Taking part in another study
 Getting no treatment
 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.
Talk to your doctor about your choices before you decide if you will take part in this
study.
Will my medical information be kept private?
We will do our best to make sure that the personal information in your medical record
will be kept private. However, we cannot guarantee total privacy. Your personal
information may be given out if required by law. If information from this study is
published or presented at scientific meetings, your name and other personal information
will not be used.
Organizations that may look at and/or copy your medical records for research, quality
assurance, and data analysis include:
North Central Cancer Treatment Group (NCCTG)
European Organization for Research and Treatment of Cancer (EORTC)
Radiation Therapy Oncology Group (RTOG)
Southeast Cancer Control Consortium (SCCC) Operations Office
Cancer Trials Support Unit (CTSU) and its representatives
Food and Drug Administration (FDA)
National Cancer Institute (NCI) and its representatives
Office for Human Research Protections (OHRP)
Qualified representative of European Authorities
Possible other federal or state government agencies
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Page 3 of 5
Participant Initials _____
IRB Approval _______________
Version Date: 2/25/11; Amendment #3
Broadcast: 3/8/11
CTSU N0577
Southeast Cancer Control Consortium Consent Form
SCREENING CONSENT FOR 1P/19Q DELETION STATUS
If your record is used or given out for governmental purposes, it will be done under
conditions that will protect your privacy to the fullest extent possible consistent with laws
relating to public disclosure of information and law-enforcement responsibilities of the
agency. These agencies may review the research to see that it is being done safely
and correctly.
You authorize the use of clinical information contained in your records, but any
publication which includes such information or data shall not reveal your name, show
your picture or contain any other personally identifying information, except as otherwise
required by law.
What are the costs of taking part in this research study?
You and/or your health plan/ insurance company will not need to pay for any of the
testing that will be done as part of this screening process. However, if you take part in
one of the treatment trials, you and/or your health plan/ insurance company will need to
pay for all of the costs of treating your cancer. Some health plans will not pay these
costs for people taking part in studies. Check with your health plan or insurance
company to find out what they will pay for. Taking part in this study may or may not cost
your insurance company more than the cost of getting regular cancer treatment.
You will not be paid for taking part in this study.
For more information on clinical trials and insurance coverage, you can visit the National
Cancer Institute’s Web site at http://cancer.gov/clinicaltrials/understanding/insurancecoverage. You can print a copy of the “Clinical Trials and Insurance Coverage”
information from this Web site.
Another way to get the information is to call 1-800-4-CANCER (1-800-422-6237) and
ask them to send you a free copy.
What are my rights if I take part in this research 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.
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Page 4 of 5
Participant Initials _____
IRB Approval _______________
Version Date: 2/25/11; Amendment #3
Broadcast: 3/8/11
CTSU N0577
Southeast Cancer Control Consortium Consent Form
SCREENING CONSENT FOR 1P/19Q DELETION STATUS
Who can answer my questions about the study?
For questions about the study or a research-related injury, contact your doctor,
_________________, at # _____________________. You may ask your doctor for
further information on the risks, benefits or alternative treatments.
For questions about your rights as a research participant, contact the
___________________ Institutional Review Board (which is a group of people at the
hospital in the community where you receive treatment who review the research to
protect your rights) at # __________________ (the office of ____________________).
Where can I get more information?
 You may call the National Cancer Institute’s (NCI’s) Cancer Information Service
at:
1-800-4-CANCER (1-800-422-6237) or TTY: 1-800-332-8615



You may also visit the NCI Web site at http://cancer.gov
For the NCI’s clinical trials information, go to: http://cancer.gov/clinicaltrials
For the NCI’s general information about cancer, go to:
http://cancer.gov/cancerinfo
Participant Agreement
I have been offered the opportunity to ask questions about this study and all questions
have been answered to my satisfaction. The contents of this form have been explained
to me and I understand them. I agree to allow the research personnel specified above
the access to my medical records.
It may be necessary for my doctor to contact me at a future date regarding new
information about the treatment I received; therefore I agree to notify my doctor of any
change of address and/or telephone number.
My signature below means that I have voluntarily agreed to participate in this research
study. I will be given a copy of all 5 pages of this consent. I have read it or it has been
read to me. I may also request a copy of the study (complete study plan).
______________
(Date)
_________________________________
(Participant Signature)
I certify that I have explained to the above individual the nature and purpose, the
potential benefits, and possible risks associated with participation in the research study
and have answered any questions that have been raised.
______________
(Date)
2/25/11
_________________________________
(Signature of Person Obtaining Consent)
Page 5 of 5
CTSU N0577
SCREENING CONSENT FOR 1P/19Q DELETION STATUS
Southeast Cancer Control Consortium Withdrawal of Consent
I, _____________________________, withdraw my consent to participate in this study
and refuse to be followed and have clinical data collected from my medical records.
Participant Name ___________________________________ Study/ID #___________
(Please Print Name)
Participant Signature ____________________________________ Date ___________
Witness Signature ______________________________________ Date ___________
1/11/11
CTSU N0577
SCREENING CONSENT FOR 1P/19Q DELETION STATUS
Southeast Cancer Control Consortium Withdrawal of Treatment Consent
I, _____________________________, withdraw my consent for treatment on this study.
Even though I withdraw my consent for treatment, I will continue to be followed and
clinical data will be collected from my medical records.
Participant Name ___________________________________Study/ID #____________
(Please Print Name)
Participant Signature ____________________________________
Date __________
Witness Signature ______________________________________
Date __________
1/11/11