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Long-Term Follow-Up of Recipient of Gene Transfer Research
Sponsor: M.D. Anderson Cancer Center
Summary
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.
Official title: Long-Term Follow-Up Study of Recipients of Gene Transfer Research Protocols
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
130
Start Date
2011-12-09
Completion Date
2027-12-31
Last Updated
2026-01-07
Healthy Volunteers
Yes
Conditions
Interventions
Blood Tests
If participant received retroviral gene therapy, blood test performed to check for a type of infection called the replication-competent retrovirus (RCR). Blood (up to 4 tablespoons each time) drawn every 3 months for first year after gene transfer therapy and once a year after that.
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.
Locations (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, United States