At a glance
ClinicalIndex Comparison Record- ✓Written informed consent to participate in a gene transfer study at MD Anderson
- ✓Will receive vector or vector-treated cells at MD Anderson
- ✓Written informed consent to participate in long-term follow-up protocol for up to 15 years following gene therapy administration
- ✓Agree to allow clinical samples to be collected and stored at MD Anderson and/or NIH designated facility
- ✕Subject's gene transfer protocol is not approved at MD Anderson Cancer Center
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Long-Term Follow-Up Study of Recipients of Gene Transfer Research Protocols
In Brief
An observational study evaluating Blood Tests and Questionnaires for Retroviridae Infections and Cancer. Currently recruiting, targeting 130 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.