Follow-up Protocol for Patients With Cancer/AIDS/Skin Disease

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Active, not recruiting
CT.gov ID
NCT00001503
Collaborator
(none)
1,028
Enrollment
1
Location

Study Details

Study Description

Brief Summary

This protocol is to provide follow-up medical/surgical visits for DCS patients who are long term survivors and may not currently be a participant entered on an active research protocol. No investigational treatments or standard treatments will be administered on this protocol.

Condition or DiseaseIntervention/TreatmentPhase

    Detailed Description

    Background:
    • Patients enrolled on CCR clinical protocols may require long term follow-up to assess outcome (e.g., survival) or the effects of prior therapy.

    • Keeping the primary treatment protocols open after accrual is complete in order to follow patients for long term outcome is an administrative burden on investigators and the IRB.

    Objectives:

    -To provide follow-up for patients who are long term survivors previously enrolled Center for Cancer Research (CCR) trial but who may not currently be enrolled on a research protocol.

    Eligibility:

    -Patients who were previously enrolled on a CCR protocol and who are not eligible for an active NCI intramural primary research protocol.

    Design:
    • The medical procedures/tests will be based on the patient's diagnosis, treatment and supporting clinical information. This is a follow-up study in which only standard tests and procedures are to be performed.

    • Clinical information that is relevant to the patients prior protocols will be collected for research purposes.

    • 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
    Actual Enrollment :
    1028 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Follow-up for Patients Previously Enrolled on the Center for Cancer Research Protocols
    Actual Study Start Date :
    Sep 19, 1996

    Arms and Interventions

    ArmIntervention/Treatment
    1/All Patients

    Patients who were previously enrolled on a CCR protocol and need follow-up by CCR Investigators.

    Outcome Measures

    Primary Outcome Measures

    1. To provide follow-up for patients who are long term survivors previously enrolled Center for Cancer Research (CCR) trial but who may not currently be enrolled on a research protocol [30 years]

      Provision of a mechanism to follow selected CCR patients when their protocols have been terminated.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Months and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • ELIGIBILITY CRITERIA:

    Patients of any age who were previously enrolled on a CCR protocol.

    Not eligible for or unwilling to participate in an active NCI intramural primary research protocol.

    CCR investigator decides it is in the best interests of the patient and the CC for the patient to be seen in follow-up visits at the NIH.

    Patient or Legally Authorized Representative (LAR)/guardian is able to provide informed consent.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1National Institutes of Health Clinical Center, 9000 Rockville PikeBethesdaMarylandUnited States20892

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: James L Gulley, 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:
    NCT00001503
    Other Study ID Numbers:
    • 960071
    • 96-C-0071
    • NCT00296075
    First Posted:
    Nov 4, 1999
    Last Update Posted:
    Dec 2, 2021
    Last Verified:
    Aug 31, 2021
    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)

    Study Results

    No Results Posted as of Dec 2, 2021