CancerNCT04750915
NIH-AARP Diet and Health Secondary Research Study Based on OH95CN025 Data
An observational study of Cancer and Mortality, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 71 years
- Conditions the study is for
- Cancer, Mortality, Chronic Diseases
- How many people
- 566,398 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2021to 31 Dec 2050
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the detailed description
Study Description:
The purpose of this study is to analyze the data that have been collected as part of the NIH-AARP Diet and Health Cancer study (OH95CN025), a historical cohort. In this study we seek to continue to conduct research that investigates relations among diet, lifestyle, cancer, mortality and chronic diseases, continue to passively follow-up on study participants through linkages to cancer registries and vital status databases, but no new study activities will be requested from the study participants.
Objective:
To clarify long-term associations between diet, lifestyle, cancer, mortality and chronic diseases using previously collected data and planned linkages with air pollution estimates, microbiome data, cancer outcome data and mortality data.
- Conditions
- Cancer, Mortality, Chronic Diseases
- Keywords
- Nutrition, Prospective Cohort, Lifestyle Factors, Cancer, Mortality, Natural History
- Medical subject headings
- Neoplasms, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident Cancer
All cancers
Measured: 12/31/2030
Chronic Diseases
Chronic diseases
Measured: 12/31/2030
All cause and disease specific mortality (especially cancer)
All cause and disease specific mortality
Measured: 12/31/2030
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start9 Feb 2021
- Primary completion31 Dec 2050 (estimated)
- Study completion31 Dec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 566,398 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Emily J Vogtmann, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04750915
- Sponsor's protocol ID
- 10000195
- Other IDs
- 000195-C
- Status last verified
- 17 Sep 2026
- First submitted
- 10 Feb 2021
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIH-AARP Diet and Health Secondary Research Study Based on OH95CN025 Data
- ClinicalTrials.gov ID
- NCT04750915
- Acronym / sponsor ID
- 10000195
- Conditions
- Cancer, Mortality, Chronic Diseases
- Keywords
- Nutrition, Prospective Cohort, Lifestyle Factors, Cancer, Mortality, Natural History
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 566,398 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 31 Dec 2050 (estimated)
- Study completion
- 31 Dec 2050 (estimated)
- First posted
- 11 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Description:
The purpose of this study is to analyze the data that have been collected as part of the NIH-AARP Diet and Health Cancer study (OH95CN025), a historical cohort. In this study we seek to continue to conduct research that investigates relations among diet, lifestyle, cancer, mortality and chronic diseases, continue to passively follow-up on study participants through linkages to cancer registries and vital status databases, but no new study activities will be requested from the study participants.
Objective:
To clarify long-term associations between diet, lifestyle, cancer, mortality and chronic diseases using previously collected data and planned linkages with air pollution estimates, microbiome data, cancer outcome data and mortality data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 50 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incident Cancer
Time frame: 12/31/2030
All cancers
Chronic Diseases
Time frame: 12/31/2030
Chronic diseases
All cause and disease specific mortality (especially cancer)
Time frame: 12/31/2030
All cause and disease specific mortality
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily J Vogtmann, Ph.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Mortality, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident Cancer (time frame: 12/31/2030). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.