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CTSU/GOG 0218 Southeast Cancer Control Consortium Consent Form Authorization (Permission) to Use or Disclose (Release) Identifiable Health Information For Research Participant’s Name: ____________________________________________________________ Birth Date: ____________________ 1. What is the purpose of this form? The Cancer Trials Support Unit (CTSU) is an organization that coordinates research for many National Cancer Institute (NCI) sponsored national cooperative groups to learn about the causes of cancer, and how to prevent and treat cancer. Researchers from one of these groups would like to use your health information for research: Cancer and Leukemia Group B (CALGB) National Surgical Adjuvant Breast and Bowel Project (NSABP) Radiation Therapy Oncology Group (RTOG) Southwest Oncology Group (SWOG) Gynecologic Oncology Group (GOG) This information may include data that identifies you. Please carefully review the information below. If you agree that researchers can use your identifiable health information, you must sign and date this form to give them your permission. 2. What health information do the researchers want to use? The researchers want to copy and use the portions of your medical record that they will need for their research. If you enter a CTSU coordinated research study, information that will be used and/or released may include your complete medical record, and in particular, the following: The history and diagnosis of your disease Specific information about treatments you received Information about other medical conditions that may affect your treatment Medical data, including laboratory test results, tumor measurements, CT scans, MRIs, X-rays, photographs of radiation therapy target areas, and pathology results Information on side effects (adverse events) you may experience, and how these were treated Long-term information about your general health status and the status of your disease Tissue and/or blood samples, associated data related to the analysis of the samples Numbers or codes that may identify you, such as your Social Security Number and medical record number. You may request a blank copy of the CTSU data forms from __________________ ________________________________ (SCCC Study Coordinator or Clinical Research Professional) to learn what information will be shared. 11/15/05 Page 1 of 5 Participant Initials ____ CTSU/GOG 0218 Southeast Cancer Control Consortium Consent Form 3. Why do the researchers want my health information? ___________________________________________________________ (name of site) will collect your health information and share it with CTSU and ___________ if you enter this CTSU research study, or to evaluate your eligibility for a study. The CTSU researchers will use your information for the following cancer research study(ies). Study Title and Purpose of Study: A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo Versus Carboplatin and Paclitaxel Plus Concurrent Bevacizumab (NSC #704865, IND #7921) Followed by Placebo, Versus Carboplatin and Paclitaxel Plus Concurrent and Extended Bevacizumab, in Women with Newly Diagnosed, Previously Untreated, Suboptimal Advanced Stage Epithelial Ovarian and Primary Peritoneal Cancer You are being asked to take part in this study because you have ovarian or peritoneal primary cancer. Standard chemotherapy for your type of cancer usually consists of two drugs called carboplatin and paclitaxel, which are given every three weeks for a total of six treatments. Chemotherapy is given to control the growth of your cancer and to lower the chance of it coming back. This treatment has been found to be effective, but longterm cure is uncommon. Many patients will eventually develop recurrent cancer and need additional treatment. 1/16/06 A newer drug, called Bevacizumab, has recently been approved by the U.S. Food and Drug Administration (FDA) for use in combination with chemotherapy in patients with colon cancer that has spread to distant sites in the body. The Bevacizumab being provided in this study is for investigational use only and is not the commercially marketed product. The commercially available Bevacizumab is marketed under the name of Avastin. Investigational Bevacizumab and commercially available Avastin may be produced at separate facilities. Although investigational bevacizumab and Avastin are expected to be very similar, it is possible that some differences may exist. Bevacizumab is thought to work by blocking the effect of Vascular Endothelial Growth Factor, (VEGF) a protein made by tumors which can stimulate growth of tumor cells as well as blood vessels in and around tumors in some patients. Bevacizumab has been given alone on a clinical trial for patients with ovarian and primary peritoneal cancer whose tumors have recurred (come back). Approximately 18% of the 62 patients’ tumors have shrunk, and 39% have not grown in at least six months. The purpose of this study is to compare the combination of carboplatin, paclitaxel and Bevacizumab to the standard combination of carboplatin and paclitaxel alone. Effectiveness of treatment will be measured in terms of survival, time without evidence of cancer growth and quality of life (wellness and physical functioning). In this study, you will receive treatment with either: 1) the combination of carboplatin, paclitaxel and Bevacizumab; 2) the combination of carboplatin, paclitaxel and Bevacizumab followed by extended Bevacizumab treatment for 15 months of total treatment; or 2) the combination of carboplatin and paclitaxel alone. Researchers in the 11/15/05 Page 2 of 5 Participant Initials ____ CTSU/GOG 0218 Southeast Cancer Control Consortium Consent Form Gynecologic Oncology Group and the National Cancer Institute have determined that the only way to compare the effectiveness and side effects of these three treatments is to substitute a placebo (fluid without Bevacizumab) for Bevacizumab when Bevacizumab is not given. The treatment assigned will be based on a process called randomization, which is explained below. In addition to the treatment part of this study the researchers plan to create a bank to store tumor tissue and serum (blood) samples from patients who go on this study. This will be done in order to perform laboratory studies that will provide important data on how patients’ cancer responds to treatment and how it relates to survival. You will be asked to sign a separate section of the Informed Consent if you agree to participate. 4. Who will be able to use my health information? ___________________________________________________________ (name of site) will use your health information for research. As part of this research, they may give your information to the following Groups taking part in the research. _____________________________________ (name of site) may also permit staff from these Groups to review your original records as required by law for audit purposes. Southeast Cancer Control Consortium (SCCC) Operations Office Cancer Trials Support Unit (CTSU) and its representatives National Surgical Adjuvant Breast and Bowel Project (NSABP) Gynecologic Oncology Group (GOG) and its representatives National Cancer Institute (NCI) and its representatives Food and Drug Administration (FDA) Office for Human Research Protections (OHRP) Institutional Review Board (IRB) at your hospital A qualified representative of Genetech, Inc. Possible other federal or state government agencies Central laboratories:______________________where tissue samples (blood, bone marrow etc.,) are reviewed. 5. How will information about me be kept private? CTSU will keep all identifiable health information confidential to the extent possible, even though they and other federal research groups are not subject to the same federal privacy laws governing clinical centers. CTSU will not release identifiable health information about you to others except as authorized by this form, or required by law. However, once your information is given to other organizations that are not required to follow federal privacy laws, we cannot assure that the information will remain protected. 6. What happens if I do not sign this authorization form? If you do not sign this authorization form, you will not be able to take part in a research study for which you are being considered. 11/15/05 Page 3 of 5 Participant Initials ____ CTSU/GOG 0218 Southeast Cancer Control Consortium Consent Form 7. If I sign this form, will I automatically be entered into the research study? No, you cannot be entered into any research study without further discussion and separate consent. After discussion, you may decide to take part in the research study. At that time, you will be asked to sign a separate research consent form. 8. What happens if I want to withdraw my authorization? You can change your mind at any time and withdraw this authorization. This request for withdrawal must be made in writing. Beginning on the date you withdraw your authorization, no new identifiable health information will be used for research. However, researchers may continue to use the health information that was provided before you withdrew your permission. If you sign this form and enter the research study, but later change your mind and withdraw your authorization, you will be removed from the research study at that time. To withdraw your authorization, please contact the person below. [He/she] will make sure your written request to withdraw your authorization is processed correctly. Contact Person: ________________________________________________________________ Title: ____________________________________________________________ Address: ________________________________________________________________ Phone: _________________________________ Fax: ____________________ 9. How long will this authorization last? If you agree by signing this form that researchers can use your identifiable health information, this authorization has no expiration date. However, as stated above, you can change your mind and withdraw your permission at any time. 10. What are my rights regarding my identifiable health information? You have the right to refuse to sign this authorization form. You have the right to review and/or copy records of your health information kept by _____________________________________ (name of site). You do not have the right to review and/or copy records kept by CTSU and _________ or other researchers associated with the research study. ****************************************************************************** Signatures You will be given a copy of this authorization upon request. I agree that my identifiable health information may be used and disclosed for research purposes described in this form. 11/15/05 Page 4 of 5 Participant Initials ____ CTSU/GOG 0218 Southeast Cancer Control Consortium Consent Form Signature of Participant or Participant’s Legal Representative: ________________________________________________ Date: ________________ Printed Name of Participant: ______________________________________________________ Printed Name of Legal Representative (if any): _______________________________________ Representative’s Authority to Act for Participant: _____________________________________ Signature of Person Obtaining Authorization: ___________________________ Date: ________ Printed Name of Person Obtaining Authorization: _____________________________________ 11/15/05 Page 5 of 5