Long-term follow-up of people who received gene therapy in cancer studies
Follows adults who previously received gene therapy to check for harmful side effects.
Plain-language title generated from the registry record
Registry title: Gene Therapy Follow up Protocol for Subjects Previously Enrolled in NCI Center for Immuno-Oncology Studies
Key facts
- Where
- Bethesda, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 120 years old?
Source: NCT04266093, who can take part
Where in United States
- National Institutes of Health Clinical CenterBethesda, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Cancer Institute (NCI)
- Trial code
- NCT04266093
- Record updated
- 2 October 2026
- Original description
Background:Read full original descriptionShow less
Gene Therapy Follow up Protocol for Subjects Previously Enrolled in NCI Center for Immuno-Oncology Studies
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.
Exclusion: -Children.
INCLUSION CRITERIA:; Subjects who have enrolled on an applicable NCI CIO gene therapy treatment protocol. Age >= 18 years. Note: Children are generally excluded from CIO gene therapy studies and inclusion on this follow-up study will be limited to 18 years and older.