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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Melanoma; Adenocarcinoma; Neuroendocrine Tumors; Carcinoma NOS

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

• 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.

INCLUSION CRITERIA:

-For Cohort B: Women of child-bearing potential who are pregnant or plan to become pregnant because of the potentially dangerous effects of the investigational treatments administered on NCI-SB treatment protocols.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
A/Gene Therapy; Patients who have received gene therapy
B/Non-Gene Therapy; Patients who have not received gene therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	15 years
Survival	Follow subjects who have participated in research studies in the NCI Surgery Branch until time of death	Until time of death

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Steven A Rosenberg, M.D., National Cancer Institute (NCI)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2009

Study Registration Dates

• First Submitted: June 17, 2009
• First Submitted That Met QC Criteria: June 17, 2009
• First Posted (Estimated): June 18, 2009

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: January 18, 2024

More Information

Terms related to this study

• Keywords: Gene Therapy; Carcinoma; Natural History; Adenocarcinoma; Melanoma; Neuroendocrine Tumors; Follow-Up; Delayed Toxicity
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Adenocarcinoma; Melanoma; Neuroendocrine Tumors
• Other Study ID Numbers: 090161; 09-C-0161

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: .All IPD recorded in the medical record will be shared with intramural investigators upon request.
• IPD Sharing Time Frame: Clinical data will be available during the study and indefinitely.
• IPD Sharing Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No