Screening Protocol to Evaluate Volunteers for NIA Approved Studies

Sponsor
National Institute on Aging (NIA) (NIH)
Overall Status
Completed
CT.gov ID
NCT02091271
Collaborator
(none)
5,000
1
204.4
24.5

Study Details

Study Description

Brief Summary

The National Institute on Aging (NIA) Intramural Research Program (IRP) has a number ofiRB approved research studies involving human subjects, both normal volunteers and patients. As a means of identifying interested volunteers and other participants in the research process, this screening mechanism is established to identif'y potential eligible participants for NlA protocols.

To participate, volunteers/patients must meet the specific requirements of at least one of the available NlA research studies; this protocol serves as a first step for admitting volunteers/patients to an appropriate approved protocol and creating a contact database for approved NlA studies.

This protocol will facilitate their recruitment into NIA approved studies and provide NlA staff the opportunity to examine subjects where diagnostic observations can be documented and evaluated for research potential.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The screening protocol is designed to evaluate volunteers/patients for participation in IRB approved clinical studies of the National Institute on Aging (NIA). An additional purpose of this protocol is to develop a registry of individuals who have been evaluated through the NIA Clinical Research Unit screening clinic. To participate, volunteers/patients must meet the specific requirements of at least one of the available NIA research studies. This protocol serves as a first step for admitting volunteers/patients to an appropriate approved protocol, and it is used to develop a registry of individuals who meet eligibility criteria for existing research projects.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    5000 participants
    Time Perspective:
    Other
    Official Title:
    Screening Protocol to Evaluate Volunteers for NIA Approved Studies
    Actual Study Start Date :
    Feb 28, 2003
    Actual Primary Completion Date :
    Mar 11, 2020
    Actual Study Completion Date :
    Mar 11, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Develop a registry of individuals who meet eligibility criteria forexisting research projects [ongoing]

    2. Evaluate volunteers/patients for participation in IRB approved clinicalstudies at NIA [ongoing]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    • INCLUSION CRITERIA:
    1. All volunteers/patients who meet the criteria of an approved NIA protocol.

    2. People with diagnosed or undiagnosed conditions

    3. Patients may be eligible if they have rare, unusual, interesting or unknown conditions that require diagnosis

    EXCLUSION CRITERIA:
    1. Subjects unable to provide informed consent.

    2. The volunteer/patient does not meet the criteria of any approved NIA protocol and does not wish to remain in the contact database for future studies.

    3. Volunteer/patient has contacted the NIA Clinical Research Protocol Office and notified them that they would like to be removed and no longer contacted for NIA approved studies. They will be removed.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Institute of Aging, Clinical Research Unit Baltimore Maryland United States 21224

    Sponsors and Collaborators

    • National Institute on Aging (NIA)

    Investigators

    • Principal Investigator: Chee W Chia, M.D., National Institute on Aging (NIA)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Institute on Aging (NIA)
    ClinicalTrials.gov Identifier:
    NCT02091271
    Other Study ID Numbers:
    • 999903335
    • 03-AG-N335
    First Posted:
    Mar 19, 2014
    Last Update Posted:
    Mar 16, 2020
    Last Verified:
    Mar 1, 2020
    Keywords provided by National Institute on Aging (NIA)

    Study Results

    No Results Posted as of Mar 16, 2020