Download URCC U1202 - Southeast Clinical Oncology Research

URCC U1202
Southeast Cancer Control Consortium Consent Form
SERUM FGF-2, VEGF AND PLASMA ANTITHROMBIN III IN PATIENTS WITH
UNRESECTABLE PANCREATIC CANCER RECEIVING GEMCITABINE
WITH/WITHOUT DALTEPARIN
What Is A Research Study?
This consent form describes a clinical trial (research study) and what you may expect if
you decide to participate. You are encouraged to read this consent form carefully and
to ask the person who presents it any further questions you may have before making
your decision whether or not to participate. Clinical trials only include patients who
choose to take part. Please take your time to make your decision.
Why Is This Study Being Done?
This research study is being conducted by the University of Rochester Cancer Center
and its affiliates in the Community Clinical Oncology Program.
The purpose of this study (Correlative Study) is to explore the possible changes
between levels of certain growth factors in the blood and pancreatic cancer therapy.
There is reason to believe that these growth factors may be involved in recruiting blood
vessels for tumor growth. Knowing more about how the levels of these substances
change over time can help our understanding of pancreatic cancer and its therapy. The
study is being done in combination with another research study, U2200: A Prospective
Randomized Controlled Multicenter Study Of The Effect Of Dalteparin On Quality Of
Life In Unresectable Pancreatic Cancer (Phase III Study) that the researchers have
discussed with you. You must be participating in that clinical study in order to
participate in this Correlative Study. You are free to participate in the Phase III Study
(U2200), even if you decide not to participate in the Correlative Study.
How Many People Will Take Part In The Study?
Approximately 60 participants will take part in this study.
What Is Involved In The Study?
If you decide to participate in this study, in addition to completing the study
requirements for the Phase III Study, you will have two additional tubes of blood drawn
(approximately four teaspoons) at each time blood is drawn for the Phase III Study
(baseline, every 4 weeks and on completion of study). These blood samples will be
tested for growth factor levels.
What Are The Risks Of The Study?
Bruising, bleeding, pain and infection may occur where the blood samples are taken.
Sometimes, drawing blood causes people to feel lightheaded or even faint. An
additional 20mL of blood (4 teaspoons) will be taken during the Correlative Study.
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Patient Initials______
URCC U1202
Southeast Cancer Control Consortium Consent Form
Are There Benefits To Taking Part In The Study?
There are no direct benefits from your participation in this study. We hope the
information learned from this study will benefit other patients with advanced pancreatic
cancer in the future.
What Other Options Are There?
An alternative to participating in this study is not to participate.
What About Confidentiality?
Efforts will be made to keep your personal information confidential. We cannot
guarantee absolute confidentiality. Your personal information may be disclosed if
required by law.
A record of your progress will be kept in a confidential form at your hospital or doctor’s
office where you receive treatment. Organizations that may inspect and/or copy your
research and medical records (blood samples, x-rays, scans, pathology slides, etc.) for
quality assurance and data analysis include groups such as:
Southeast Cancer Control Consortium (SCCC) Operations Office
University of Rochester Cancer Center (URCC)
National Cancer Institute (NCI)
Food and Drug Administration (FDA)
Office for Human Research Protections (OHRP)
Institutional Review Board (IRB) at your hospital
Qualified Representative of applicable drug manufacturers
Possible other federal or state government agencies
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.
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?
There is no cost for participating in this study. You will not be charged for getting your
blood drawn.
In the case of injury or illness resulting from this study, emergency medical treatment is
available but will be provided at the usual charge. No funds have been set aside to
compensate you in the event of injury.
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Patient Initials______
URCC U1202
Southeast Cancer Control Consortium Consent Form
You will receive no payment for taking part in this study.
What Are My Rights As A Participant?
Taking part in this study is voluntary. You may choose not to take part or may leave the
study at any time. Leaving the study will not result in any penalty or loss of benefits to
which you are entitled.
We will tell you about new information that may affect your health, welfare or willingness
to stay in this study.
Who Do I Call If I Have Questions Or Problems?
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 NCI’s Cancer Information Service at 1-800-4-CANCER (1-800-4226237) or TTY: 1-800-332-8615 or you may visit the Cancer Information Service
Website: http://www.cancer.gov/cis
You may visit the NCI’s Web site:
http://www.cancer.gov
This website contains comprehensive clinical trials information and accurate cancer
information.
You may also call the Project Office of the NCI Central Institutional Review Board
(CIRB) at 888-549-0715 (from the continental U.S. only).
Cancer Fax
Includes NCI information about cancer treatment, screening, prevention, and supportive
care. To obtain a contents list, dial 301-402-5874 or 800-624-2511 from a fax machine
hand set and follow the recorded instructions.
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Patient Initials______
URCC U1202
Southeast Cancer Control Consortium Consent Form
Patient Contract
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. A copy of this consent form has been given to me. I may also request a copy of
the study (complete study plan).
_______________________________
(Patient Name – Please Print)
_______________________________
(Patient Signature)
___________
(Date)
_______________________________
(Witness Name – Please Print)
_______________________________
(Witness Signature)
_____________
(Date)
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)
_________________________________
(Provider of Information Signature)
_____________
(Date)
_________________________________
(Provider of Information Signature)
(If applicable for second provider)
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URCC U1202
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.
Patient Name _____________________________ Study/ID #___________
(Please Print Name)
Patient Signature _______________________________________ Date ___________
Witness Signature ______________________________________ Date ___________
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URCC U1202
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.
Patient Name ______________________________________Study/ID #____________
(Please Print Name)
Patient Signature ______________________________________
Witness Signature ______________________________________
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Date __________
Date __________