Long-Term Follow-Up of Recipient of Gene Transfer Research
Long-Term Follow-Up Study of Recipients of Gene Transfer Research Protocols
M.D. Anderson Cancer Center
130 participants
Dec 9, 2011
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- Patient or patient's legal representative(s) provided written informed consent to participate in a gene transfer study at the University of Texas MD Anderson Cancer Center (MD Anderson).
- Patient will receive vector or vector-treated cells at MD Anderson.
- Patient or patient's legal representative(s) is/are able to provide written informed consent to participate in this long-term follow-up protocol for gene transfer participants for up to 15 years following administration of gene therapy product.
- Agree to allow clinical samples to be collected and stored at MD Anderson and/or at a NIH designated facility such as the NGVB.
Exclusion Criteria1
- \) Subject's gene transfer protocol is not approved at MD Anderson Cancer Center.
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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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT01492036