NCI launches 15-Year checkup for cell therapy volunteers
NCT ID NCT00923026
First seen Jun 26, 2026 · Last updated Aug 28, 2026 · Updated 11 times
Summary
This study is not testing a new treatment. Instead, it follows people who already received experimental cell therapies (like growing immune cells from their tumors or blood) in earlier NCI Surgery Branch trials. The goal is to monitor their health for up to 15 years, as required by the FDA, to track long-term safety and survival. About 1,150 participants with cancers like melanoma or adenocarcinoma will have regular physical exams and blood tests.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2009
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
All subjects will have previously been enrolled on an NCI Surgery Branch treatment protocol. Patients who received gene therapy will be followed as required by the FDA.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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. EXCLUSION CRITERIA: -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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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