Follow Up Protocol for Subjects Previously Enrolled on NCI Surgery Branch Studies

NCT00923026 | Enrolling By Invitation

• 2 other identifiers: 09016109-C-0161
• Study Type: observational
• Target: 1,150
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Melanoma; Adenocarcinoma; Carcinoma NOS; Neuroendocrine Tumors

Keywords

Gene Therapy; Follow-Up; Delayed Toxicity; Natural History; Adenocarcinoma; Melanoma; Neuroendocrine Tumors; Carcinoma

Outcome Measures

Primary Outcomes (1)

• Long-term follow-up

  Long-term follow-up of subjects who have participated in research studies in the NCI Surgery Branch

  Until time of death

Secondary Outcomes (2)

• Long-term follow-up for gene therapy studies

  15 years

• Survival

  Until time of death

Study Arms (2)

A/Gene Therapy

Patients who have received gene therapy

B/Non-Gene Therapy

Patients who have not received gene therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Melanoma; Adenocarcinoma; Carcinoma; Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms, Glandular and Epithelial

Study Officials

• Steven A Rosenberg, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2009
• First Posted: June 18, 2009
• Study Start: June 15, 2009
• Last Updated: April 20, 2026

Record last verified: 2026-01-22

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data will be available during the study and indefinitely.
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.

Locations

US (1)