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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. 9/25/02 Page 1 of 4 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. 9/25/02 Page 2 of 4 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. 9/25/02 Page 3 of 4 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) 9/25/02 Page 4 of 4 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 ___________ 9/25/02 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 ______________________________________ 9/25/02 Date __________ Date __________