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NCT00695279 · ClinicalTrials.gov registry record
Long Term Follow Up Of Patients Who Have Received Gene Therapy Or Gene Marked Products
A clinical trial, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- 41
- Enrollment target
NCT00695279: Completed study, sponsored by St. Jude Children's Research Hospital.
NCT00695279 is a clinical trial that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 41 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00695279 has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- 41 participants
- Enrollment target
Study Summary
This protocol (GENEFU) provides a mechanism for the 15-year followup period that the FDA requires for all participants in gene transfer protocols and assures that adequate followup can be maintained for a wide variety of participants on different individual gene therapy protocols at St. Jude Children's Research Hospital. GENEFU serves as an umbrella protocol for long-term follow-up (LTFU) for recipients of gene therapy/gene marked (GT/GM) products at St. Jude Children's Research Hospital. The FDA has recommended methods to assess the risk of delayed adverse events after GT/GM and has provided specific requirements regarding the duration and design of LTFU observations. This protocol is intended to provide LTFU in accordance with the FDA guidelines for those who received a GT/GM product as part of a St. Jude-sponsored clinical trial or compassionate use treatment plan. The protocol calls for a physical examination or general health evaluation and collection of required blood samples annually for up to 15 years after the last receipt of a GT/GM product. Goals will be to obtain clinical histories in order to detect late clinical outcomes suggestive of retroviral or lentiviral disease, including but not limited to cancer/second malignancies, neurologic disorders, autoimmune disorders, and hematologic disorders. Blood samples will be archived and tested when clinically or scientifically indicated, as in the event of development of a second malignancy. This prospective cohort study will utilize descriptive statistics in the analysis of long-term late effects outcomes. It offers a uniform approach to long-term safety monitoring in research participants who have received a gene-transduced product as part of St. Jude-sponsored GT or GM protocols and compassionate use treatment plans.
Primary Outcome
Obtain histories for detection of significant delayed medical events including hematologic, malignant, autoimmune, and neurologic events in research participants who have received an integrating vector-based gene therapy/gene marked product at St. Jude Children's Research Hospital (SJCRH).
Interventions
- PROCEDURE Venipuncture
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2007-01-04 |
| Est. Completion | 2024-10-17 |
What the finished NCT00695279 record still lists
NCT00695279 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 41 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Venipuncture is the first listed.
NCT00695279 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00695279 about?
NCT00695279 is a clinical study titled "Long Term Follow Up Of Patients Who Have Received Gene Therapy Or Gene Marked Products". This protocol (GENEFU) provides a mechanism for the 15-year followup period that the FDA requires for all participants in gene transfer protocols and assures that adequate followup can be maintained for a wide variety of participants on different individual gene therapy protocols at St. Jude Childre...
What is the current status of trial NCT00695279?
This trial is currently completed. The enrollment target is 41 participants. The study started on 2007-01-04. Estimated completion is 2024-10-17.
What interventions are being tested in trial NCT00695279?
The interventions under investigation include: Venipuncture (PROCEDURE).
Who is sponsoring clinical trial NCT00695279?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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