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RECRUITING
NCT01492036

Long-Term Follow-Up of Recipient of Gene Transfer Research

Sponsor: M.D. Anderson Cancer Center

View on ClinicalTrials.gov

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

Interventions

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). Blood (up to 4 tablespoons each time) drawn every 3 months for first year after gene transfer therapy and once a year after that.

BEHAVIORAL

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