Delivering Long-Term Health Check-Ups for Past Gene Therapy Study Participants
NCT00451022 · RecruitingThis study looks at the health of patients who previously took part in a vaccine study using gene therapy. Gene therapy uses special genetic material to help treat diseases. The study does not give any new drugs or treatments. Instead, it focuses on checking the long-term health of these patients over 15 years. Annual check-ups will help track any health changes and ensure everyone is doing well after their treatment.
Locations and contact
This trial is running at 1 location in the United States. It is currently recruiting.
United States1 location · 1 recruiting
- National Institutes of Health Clinical CenterBethesda, MarylandRecruiting
Who can join
Men and women aged 18 and older who received specific vaccines using gene therapy at the National Cancer Institute can join. Participants must be willing to take part in this follow-up study. Those who do not want to participate cannot join. Patients can also be involved in other treatments while in this study.
What happens during the trial
Participants will be in one main group for this study. They will receive annual health check-ups for up to 15 years. This includes a medical history review, physical exams, and health status checks. They will also have telephone contact for 10 years and may need blood tests for certain health checks. This helps ensure their health is monitored closely over time.
The trial team
The trial is led by the National Cancer Institute (NCI). Jennifer L Marte is the principal investigator overseeing the study.
Important dates
The study began on September 13, 2004, and is currently recruiting new participants. The latest update on the study was on June 5, 2026.
Additional information
The trial's ID number is NCT00451022. This is an observational study, meaning it is designed to watch and collect health data without giving new treatments. The study is not regulated by the FDA for any drugs or devices, and it hopes to include about 750 participants.
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