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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01492036
Status
Recruiting
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Conditions

  • Cancer
  • Retroviridae Infections

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • Blood Tests — OTHER
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Dec 9, 2011
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
130 participants (estimated)

Arms

  • Arm: Gene Transfer Therapy
    Study participants receiving gene therapy product at MD Anderson Cancer Center

Primary Outcome Measure

Document Long-Term Safety of Gene-Transfer Research [ Time Frame: 15 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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University of Texas MD Anderson Cancer Center· Houston, TX

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