NCT04750915

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
566,398

participants targeted

Target at P75+ for all trials

Timeline
300mo left

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Feb 2021Dec 2050

Study Start

First participant enrolled

February 9, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 10, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2021

Completed
29.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2050

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2050

Last Updated

April 15, 2025

Status Verified

April 10, 2025

Enrollment Period

29.9 years

First QC Date

February 10, 2021

Last Update Submit

April 11, 2025

Conditions

Keywords

NutritionProspective CohortLifestyle FactorsCancerMortalityNatural History

Outcome Measures

Primary Outcomes (3)

  • Incident Cancer

    All cancers

    12/31/2030

  • Chronic Diseases

    Chronic diseases

    12/31/2030

  • All cause and disease specific mortality (especially cancer)

    All cause and disease specific mortality

    12/31/2030

Study Arms (1)

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

Eligibility Criteria

Age50 Years - 71 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

NeoplasmsChronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rashmi Sinha, Ph.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2021

First Posted

February 11, 2021

Study Start

February 9, 2021

Primary Completion (Estimated)

December 31, 2050

Study Completion (Estimated)

December 31, 2050

Last Updated

April 15, 2025

Record last verified: 2025-04-10

Locations