Long-term follow-up of people previously treated with NCI cell-based gene therapy
Follows people with melanoma or other cancers after earlier NCI gene therapy treatment.
Plain-language title generated from the registry record
Registry title: Follow Up Protocol for Subjects Previously Enrolled on NCI Surgery Branch Studies
Key facts
- Where
- Bethesda, United StatesSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who were treated in an earlier NCI Surgery Branch study, including gene therapy studies. They are followed for up to 15 years.
- Age
- 18 years or older
- Sex
- All sexes can join
- Earlier treatment
- Must have received treatment in an NCI Surgery Branch study, including gene therapy studies. Can join while also taking part in an active treatment study.
Main reasons for not taking part
- Cohort B: people who can become pregnant and are pregnant or plan to become pregnant
- Cohort B: people who cannot give informed consent themselves
Read by machine on 10 November 2026.
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
- NCT00923026
- Record updated
- 9 November 2026
- Original description
Background:Read full original descriptionShow less
Follow-Up Protocol for Subjects Previously Enrolled on NCI Surgery Branch Studies
Background:
The NCI Surgery Branch has developed experimental therapies that involve taking white blood cells from participants' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient.
Objective:
This study will allow participants to be followed for up to 15 years following treatment on an NCI Surgery Branch Gene Therapy Trial as required by the FDA.
Eligibility:
Participants must have been enrolled on an NCI Surgery Branch Gene Therapy Protocol
Design
Participants will be followed with a physical examination and blood tests for up to 15 years as required by the FDA
...
Exclusion: -For Cohort B: Individuals of child-bearing potential (IOCBP) who are pregnant or plan to become pregnant because of the potentially dangerous effects of the investigational treatments administered on NCI-SB treatment protocols.
INCLUSION CRITERIA:; Age greater than or equal to 18 years; Participants who have received treatment on an NCI-SB protocol, including gene therapy protocols. (Note: Participants may be enrolled on this protocol and, at the same time, participate in an active treatment study); For Cohort A:Ability of participant or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document. For Cohort B: Participant is able to provide informed consent.