NIH-AARP Diet and Health Secondary Research Study Based on OH95CN025 Data

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Active, not recruiting
CT.gov ID
NCT04750915
Collaborator
(none)
566,398
1
358.7
1579.2

Study Details

Study Description

Brief Summary

Background:

The NIH and the American Association of Retired Persons (AARP) conducted a Diet and Health Study. It studied the links between diet, cancer, and cause of death in a group of middle-aged people in the U.S. Researchers want to learn more about how diet and lifestyle can affect cancer and mortality.

Objective:

To clarify links between diet, lifestyle, cancer, death, and chronic diseases.

Eligibility:

AARP members ages 50 to 71 who took part in study #OH95CN025 and lived in California, Florida, Pennsylvania, New Jersey, North Carolina, Louisiana, Atlanta, or Detroit in 1995 1996.

Design:

This study will use existing data and samples. Participants will not be contacted.

Participants personal data, like name, date of birth, and address, will be used. This data will be kept private. Their data and samples will get a unique ID.

Data from other follow-up studies will be used.

Cancer outcome data will be obtained from the 8 sample areas. Many participants have moved to Arizona, Nevada, and Texas. Data will be obtained from those states as well.

Cause of death and date of death will be obtained from the National Death Index.

Cheek swab samples were gathered from 2004 to 2005. They will be used to study the oral microbiome.

The University of Washington (UW) will be added as a study site. UW will study air pollution.

The process of linking with the Virtual Pooled Registry Cancer Linkage System will be explored. It uses one system. Right now, 11 state systems are used to get and link data.

Paper records will be stored in locked file rooms. Electronic data will be stored on secure servers.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Study Description

    The purpose of this study is to analyze the data that have been collected as part of NIH-AARP study (OH95CN025), a historical cohort; in this study we seek to continue to conduct research, but no new study activities will be requested from the study participants.

    Objective

    To examine relationships between diet, lifestyle, and cancers by means of a prospective cohort design

    To examine relationships between diet, lifestyle, and mortality by means of a prospective cohort design

    To examine relationships between diet, lifestyle, and chronic diseases

    Study Population

    Data and samples from 566,398 members of the AARP (formally the American Association of Retired Persons), aged 50-71 years, and who resided in one of six states (California, Florida, Pennsylvania, New Jersey, North Carolina, and Louisiana) or in two metropolitan areas (Atlanta, Georgia and Detroit, Michigan) in 1995-1996

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    566398 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    NIH-AARP Diet and Health Secondary Research Study Based on OH95CN025 Data
    Actual Study Start Date :
    Feb 9, 2021
    Anticipated Primary Completion Date :
    Dec 31, 2050
    Anticipated Study Completion Date :
    Dec 31, 2050

    Arms and Interventions

    Arm Intervention/Treatment
    AARP

    Members of AARP, aged 50-71 years and who resided in one of six states or in two metropolitan areas in the United States

    Outcome Measures

    Primary Outcome Measures

    1. Incident Cancer [12/31/2030]

      All cancers

    2. Chronic Diseases [12/31/2030]

      Chronic diseases

    3. All cause and disease specific mortality (especially cancer) [12/31/2030]

      All cause and disease specific mortality

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 71 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • INCLUSION CRITERIA:

    • AARP members

    • aged 50 to 71 years

    • resided in one of six states (California, Florida, Pennsylvania, New Jersey, North Carolina, and Louisiana) or in two metropolitan areas (Atlanta, Georgia and Detroit, Michigan) in 1995-1996

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Cancer Institute (NCI) Bethesda Maryland United States 20892

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Rashmi Sinha, Ph.D., National Cancer Institute (NCI)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT04750915
    Other Study ID Numbers:
    • 10000195
    • 000195-C
    First Posted:
    Feb 11, 2021
    Last Update Posted:
    Jul 7, 2022
    Last Verified:
    Dec 20, 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)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 7, 2022