Long-Term Follow-Up of Recipient of Gene Transfer Research
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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Long-Term Follow-Up Study of Recipients of Gene Transfer Research Protocols|
- Document Long-Term Safety of Gene-Transfer Research [ Time Frame: 15 years ] [ Designated as safety issue: No ]First 5 years following infusion of vector or vector-treated cells: Participants evaluated on annual basis. Years 6 to 15 following infusion of vector or vector-treated cells: Participants mailed questionnaires. Participants in retroviral studies: Up to 60 mL (max 1 mL/kg) blood will be obtained to check for replication-competent retrovirus (RCR) every 3 months during the first year, and then blood archived annually thereafter. Replication competent vector testing performed when there is a clinical indication or when requested by the FDA.
Biospecimen Retention: Samples With DNA
Study visits once a year during Years 1-5. Blood (about 2-4 tablespoons each time) will be drawn for routine tests. If retroviral gene transfer therapy received, blood (up to 4 tablespoons each time) will be drawn every 3 months for the first year after gene transfer therapy and once a year after that. (If joining study more than a year after gene transfer therapy, RCR test will be performed once a year for all 15 years of the study.)
|Study Start Date:||December 2011|
|Estimated Primary Completion Date:||December 2026 (Final data collection date for primary outcome measure)|
Gene Transfer Therapy
Study participants will have received the gene therapy product at M.D. Anderson Cancer Center prior to participating in this protocol.
Other: Blood Tests
If participant received retroviral gene therapy, blood test performed to check for a type of infection called the replication-competent retrovirus (RCR). For this test, blood (up to 4 tablespoons each time) will be drawn every 3 months for the first year after gene transfer therapy and once a year after that. (If joining this study more than a year after gene transfer therapy, however, this RCR test will be performed once a year for all 15 years of the study.)
Other Name: Blood drawBehavioral: Questionnaires
Once a year during Years 1-5, questionnaire completions that asks about medical history (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.
Once a year during Years 6-15, completion of mailed questionnaire. Participant will be asked about medical history (including if participant has had any children since the infusion) and whether there have been any changes in contact information. The questionnaires should take about 15-30 minutes each time.
Other Name: Surveys
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|Contact: Laurence JN Cooper, MD,PHD||713-792-6620|
|United States, Texas|
|UT MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Laurence JN Cooper, MD, PHD||UT MD Anderson Cancer Center|