Long-Term Follow-Up of Recipient of Gene Transfer Research
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.
Conditions:
🦠 Retroviridae Infections 🦠 Cancer
🗓️ Study Start (Actual) 9 December 2011
🗓️ Primary Completion (Estimated) 31 December 2026
✅ Study Completion (Estimated) 31 December 2027
👥 Enrollment (Estimated) 130
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Houston, Texas, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. 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).
    • 2. Patient will receive vector or vector-treated cells at MD Anderson.
    • 3. 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.
    • 4. 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 Criteria:

    • 1) Subject's gene transfer protocol is not approved at MD Anderson Cancer Center.
Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 12 December 2011
  • First Submitted that Met QC Criteria 12 December 2011
  • First Posted 14 December 2011

Study Record Updates

  • Last Update Submitted that Met QC Criteria 16 July 2024
  • Last Update Posted 18 July 2024
  • Last Verified July 2024