MelanomaNCT00923026
Follow Up Protocol for Subjects Previously Enrolled on NCI Surgery Branch Studies
An observational study of Melanoma and Adenocarcinoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Adenocarcinoma, Carcinoma NOS
- How many people
- 1,150 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2009to not given
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- -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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: 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
Read the detailed description
Background:
- Patients receiving care at the NIH Clinical Center are required to be enrolled on a clinical protocol.
- Following participation in a treatment protocol, it may be in the best interest of the patient to continue to be followed at the Clinical Center.
- The National Cancer Institute Surgery Branch (NCI-SB) conducts clinical trials utilizing gene transfer. The current U.S. Food and Drug Administration (FDA) requirements for long-term follow-up are up to fifteen years for some products. As this time-period is frequently longer than studies are expected to be open, a long-term follow-up protocol is necessary to ensure the follow-up of these participants.
Objective:
-Primary objective:
--Provide a mechanism for long-term follow-up of participants who have participated in research studies in the NCI-SB.
Eligibility:
- Age greater than or equal to 18 years.
- Participant has been enrolled on an NCI-SB treatment protocol.
Design:
- Participant will undergo physical exams, laboratory evaluation, imaging, or phone follow-up as clinically indicated.
- Procedures that entail more than minimal risk to the patient should not be performed for research purposes on this protocol.
- Conditions
- Melanoma, Adenocarcinoma, Carcinoma NOS, Neuroendocrine Tumors
- Keywords
- Gene Therapy, Follow-Up, Delayed Toxicity, Natural History, Adenocarcinoma, Melanoma, Neuroendocrine Tumors, Carcinoma
- Medical subject headings
- Melanoma, Adenocarcinoma, Carcinoma, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A/Gene Therapy | Patients who have received gene therapy | |
| B/Non-Gene Therapy | Patients who have not received gene therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term follow-up
Long-term follow-up of subjects who have participated in research studies in the NCI Surgery Branch
Measured: Until time of death
Secondary outcomes (2)
Long-term follow-up for gene therapy studies
Collection of long-term, follow-up information on subjects who have participated in gene transfer studies as required by the FDA and other regulatory groups
Measured: 15 years
Survival
Follow subjects who have participated in research studies in the NCI Surgery Branch until time of death
Measured: Until time of death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study start15 Jun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Steven A Rosenberg, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00923026
- Sponsor's protocol ID
- 090161
- Other IDs
- 09-C-0161
- Status last verified
- 19 Oct 2026
- First submitted
- 17 Jun 2009
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request.