Gene Therapy Follow up Protocol for Subjects Previously Enrolled in NCI Center for Immuno-Oncology Studies
2 other identifiers
observational
1,000
1 country
1
Brief Summary
Background: Gene therapy is closely followed by the U.S. Food and Drug Administration (FDA). The FDA requires researchers to conduct long-term follow-up of people who have had the treatment. This study collects data on people who have had gene therapy and sends it to the FDA. The data does not include participants names. Objective: To contact current or past participants of gene therapy protocols at least once a year for up to 15 years to ensure they have not had any harmful side effects. Eligibility: People aged 18 and older who have had gene therapy in a National Cancer Institute study Design: Participants will give their address and telephone number. They will also give and the address and phone number of 1 or 2 other people who will know where they are. For the first year after gene therapy, participants will give blood samples 3 times (at 3, 6, and 12 months). For the next 4 years, they may have a physical exam and laboratory tests with a home physician. They will get a kit to mail in blood samples. Or they can visit the NIH Clinical Center. They will be asked if they have had any signs of neurological, autoimmune, or blood disorders, or any new cancers. For years 6 to 15, participants will be contacted yearly via phone or email and asked questions about their health. They may give blood samples. When the participant dies, if researchers think the death was caused by gene therapy, they will ask the participant s family to allow an autopsy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2020
CompletedFirst Posted
Study publicly available on registry
February 12, 2020
CompletedStudy Start
First participant enrolled
May 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2035
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2050
May 5, 2026
December 30, 2025
15.4 years
February 11, 2020
May 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To provide long term follow up of patients previously enrolled on treatment protocols in the NCI CIO.
List of long time adverse event frequency after Gene therapy drug
15 years
Study Arms (1)
Cohort 1
Subjects who have enrolled on an applicable NCI CIO gene therapy treatment protocol.
Interventions
Observation/ Gene Therapy Long-term Follow-up. Subjects who have enrolled on an applicable NCI CIO gene therapy treatment protocol.
Eligibility Criteria
To facilitate collection of long term follow up information on subjects who have participated in gene transfer studies as required by the U.S. Food and Drug Administration and other regulatory groups
You may not qualify if:
- Children
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scott M Norberg, D.O.
National Cancer Institute (NCI)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2020
First Posted
February 12, 2020
Study Start
May 8, 2020
Primary Completion (Estimated)
October 1, 2035
Study Completion (Estimated)
October 1, 2050
Last Updated
May 5, 2026
Record last verified: 2025-12-30