Eligibility Screening for the NIH Intramural Research Program Clinical Protocols

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Enrolling by invitation
CT.gov ID
NCT00026754
Collaborator
(none)
24,000
1

Study Details

Study Description

Brief Summary

The purpose of this protocol is to provide patients with adequate informed consent to understand that screening tests with minimal health risk will be performed to evaluate their eligibility for a research study. The protocol makes it clear that patients initial visit to the intramural clinical program may include screening studies that are not medically necessary for disease management, but are done purely for research purposes.

Patients with a known or suspected diagnosis of cancer, HIV infection, skin disorder or immunodeficiency who are being considered for enrollment in a National Cancer Institute intramural clinical research protocol will participate in this consent protocol. It informs patients of screening tests and procedures involving minimal risk that are done for research purposes only, including blood tests, electrocardiogram, standard X-rays (e.g., chest X-ray), bone films, computed tomography (CT), magnetic resonance imaging (MRI), and nuclear medicine studies. It explains that other eligibility screens that are more invasive and involve greater risk, such as a biopsy, will require separate consent.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Background:

    Patients and healthy volunteers who are being evaluated for NIH Intramural Research Program (IRP) protocols must be screened to determine whether they meet the eligibility criteria prior to enrollment.

    Objectives:

    Evaluate patient or healthy volunteer eligibility for participation in NIH IRP research protocols.

    Collect results of screening test for use on subsequent research protocols as baseline (e.g., pretreatment) values.

    Collect specific research samples required for the primary research protocol as part of a screening test or procedure in order to avoid from having to subject the patient to a painful procedure on multiple occasions.

    Eligibility:

    Patients and healthy volunteers who are being evaluated for and treated on protocols within the NIH IRP.

    Design:

    This protocol is not a research study of an investigational drug or device.

    Screening tests and procedures that are required by the primary research protocols are conducted in order to establish eligibility for these protocols.

    In some cases, specific research samples required for the primary research protocol may be collected during the screening process in order to avoid from having to subject the patient to a painful procedure on multiple occasions.

    Tissues and biological fluids that are obtained during the screening process will be stored.

    Once a patient or healthy volunteer completes the screening process and is either enrolled onto another NIH study or is returned to the care of their local physician they will be taken off study.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    24000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Eligibility Screening for the NIH Intramural Research Program Clinical Protocols
    Actual Study Start Date :
    Jan 14, 2004

    Arms and Interventions

    Arm Intervention/Treatment
    Cohort 1

    Patients

    Cohort 2

    Healthy Volunteers

    Outcome Measures

    Primary Outcome Measures

    1. Tissue for future research [10 years]

      Tissue remaining from collections during the screening process, either for research eligibility or as clinically indicated may be stored for future research

    2. Screening testing/results [10 years]

      Collect results of screening test for use on subsequent research protocols as baseline (e.g., pretreatment) values

    3. Research sample collection [10 years]

      Collect specific research samples required for the primary research protocol as part of a screening test or procedure in order to avoid from having to subject the patient to a painful procedure on multiple occasions

    4. Numbers of screened patients and healthy volunteers [10 years]

      Gather prospective information on the number of patients screened for a particular study and compare to those enrolled onto an interventional study or natural history study.

    5. Eligibility evaluations [10 years]

      Evaluate patient eligibility for participation in NCI/CCR research protocols

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    • INCLUSION CRITERIA:

    • Patients and healthy volunteers who are being evaluated for protocols within the NIH Intramural Research Program (IRP). Note: Participants must be > 1 month of age.

    • All patients or their parent/guardians or Legally Authorized Representative (LAR) must sign a document of informed consent indicating their understanding of the research nature and the risks of the procedures that will be performed to assess eligibility for research protocols. NOTE: It is expected that healthy adult volunteers have the capacity to consent (i.e., a LAR may not be used).

    EXCLUSION CRITERIA:

    None

    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: 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:
    NCT00026754
    Other Study ID Numbers:
    • 010129
    • 01-C-0129
    First Posted:
    Nov 15, 2001
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 17, 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 22, 2022