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

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Enrolling by invitation
CT.gov ID
NCT00923026
Collaborator
(none)
1,000
1

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Follow-Up Protocol for Subjects Previously Enrolled on NCI Surgery Branch Studies
    Actual Study Start Date :
    Jun 15, 2009

    Arms and Interventions

    Arm Intervention/Treatment
    A/Gene Therapy

    Patients who have received gene therapy

    B/Non-Gene Therapy

    Patients who have not received gene therapy

    Outcome Measures

    Primary Outcome Measures

    1. Long-term follow-up [Until time of death]

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

    Secondary Outcome Measures

    1. Long-term follow-up for gene therapy studies [15 years]

      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

    2. Survival [Until time of death]

      Follow subjects who have participated in research studies in the NCI Surgery Branch until time of death

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Institutes of Health Clinical Center Bethesda Maryland United States 20892

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00923026
    Other Study ID Numbers:
    • 090161
    • 09-C-0161
    First Posted:
    Jun 18, 2009
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Jul 25, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Cancer Institute (NCI)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 19, 2022