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The goal of this clinical research study is to collect information about the long-term safety of gene transfer therapy. This study is also designed to create a database of medical information about patients who have received gene transfer therapy, in order for researchers to track and review the long-term safety and any effects (good or bad) of gene transfer therapy.
Study Procedures for Years 1-5:
If you agree to take part in this study, you will come to the clinic for study visits once a year during Years 1-5. It is your choice whether to visit your regular local doctor or your study doctor at MD Anderson. (If you visit your regular local doctor, you will need to have your test results and blood samples mailed to the study staff.) You will receive a reminder phone call once a year, when it is time to schedule these visits.
At these visits, the following procedures will be performed:
- Blood (about 2-4 tablespoons each time) will be drawn for routine tests.
- You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate).
- You will fill out a questionnaire that asks about your medical history (your general health, the status of any medical conditions, and any illnesses or hospitalizations that may have occurred). It should take about 15-30 minutes to complete.
- You will be asked if there have been any changes in your contact information.
- If necessary to check the status of the disease, you will have scans (x-rays and/or computed tomography [CT] scans) and/or additional routine blood tests (about 1-2 tablespoons).
Study Procedures for Years 6-15:
Once a year during Years 6-15, the research staff will contact you. Either over the phone, by email, or by mail (but usually by mail, with an enclosed questionnaire), you will be asked about your medical history (including if you have had any children since the infusion) and whether there have been any changes in your contact information. The phone calls and questionnaires should take about 15-30 minutes each time.
Blood Tests for RCR:
The study doctor will tell you if the type of gene transfer therapy you received was called "retroviral" therapy. If so, you will have an additional blood test performed to check to make sure you do not have a type of infection called the replication-competent retrovirus (RCR). For this test, blood (up to 4 tablespoons each time) will drawn every 3 months for the first year after your gene transfer therapy and once a year after that. (If you join this study more than a year after your gene transfer therapy, however, this RCR test will be performed once a year for all 15 years of the study, rather than your having the blood draws every 3 months in Year 1.)
For these RCR blood tests, it is your choice whether to visit your regular local doctor your study doctor at MD Anderson. If you visit your regular local doctor, you will need to have your test results and blood samples mailed to either the National Gene Vector Biorepository and Coordinating Center (NGVB) or MD Anderson. The study staff will tell you where to have the results and samples mailed, and you will receive a kit with supplies for mailing the blood samples.
If the RCR test results during Year 1 of the study show that you do not have the RCR infection, the rest of your leftover blood samples (left over from RCR testing in Years 2-15) will be stored at MD Anderson for safety reasons. This is so researchers can study any changes in your blood (related to RCR) that may arise in Years 2-15.
Results of Study Testing:
If any of the tests that are performed in this study suggest that you may have a medical condition and/or side effect that is likely to be related to the gene transfer therapy, the study doctor will contact you. (This includes, for example, the RCR infection described above). You will receive a referral in case you would like to seek medical care for the condition and/or side effect.
Your medical information that is collected for this study will be stored in a research database at MD Anderson for use in future research related to the safety and effects of gene transfer therapy.
Length of Study Participation:
After 15 years, your participation in this study will be over unless the FDA decides that follow-up must continue.
Observational Model: Cohort, Time Perspective: Prospective
Blood Tests, Questionnaires
University of Texas MD Anderson Cancer Center
M.D. Anderson Cancer Center
Published on BioPortfolio: 2014-09-30T16:38:23-0400
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