Long-Term Safety of Gene Transfer Therapy
This study aims to understand the long-term safety of gene transfer therapy, which you may have received at MD Anderson Cancer Center. Researchers will collect information about your health over time to create a database. This will help them track any effects, good or bad, of the gene transfer therapy for up to 15 years. You may be eligible if you or your legal representative gave written consent to participate in a gene transfer study at MD Anderson and received vector (a tool used to deliver genes) or vector-treated cells there. The main goal is to document the long-term safety of this type of research.
- Study design
- This is an observational study with a planned enrollment of 130 participants. It is designed to follow participants over a long period to gather information.
- What's involved
- For the first 5 years, you will have yearly clinic visits for blood tests, a physical exam, and to complete a questionnaire. For years 6-15, research staff will contact you once a year.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 15 years to document the long-term safety of gene transfer research.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Long-Term Follow-Up of Recipient of Gene Transfer Research
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Partow Kebriaei, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Document Long-Term Safety of Gene-Transfer Research15 years
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.