Cancer, BreastAHS-2NCT03615599
Plant-based Diets and Risk of Cancer in the Adventist Health Study-2
An observational study of Cancer, Breast and Cancer, Colorectal, run by Loma Linda University at 1 site in United States.
Trial summary
The Adventist Health Study-2 is a long-term study, exploring the links between lifestyle, diet, and disease outcomes among Seventh-day Adventists. More than 96,000 church members from the U.S. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Breast, Cancer, Colorectal, Cancer, Prostate
- How many people
- 96,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2002to Dec 2028
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The sample includes Seventh-day Adventist church members living in the USA and Canada who are 30 years and older, and who are sufficiently fluent in English to complete the lengthy lifestyle questionnaire. The study population is about 65% female. Approximately 25% of the cohort are Black/African Americans . Other ethnic minorities (e.g. Asian, Hispanic) are at much lower percentages (3-4 %).
Who may be able to join
- Member of a Seventh-day Adventist church >30 years of age Ability to read English Live in the US or Canada
Who cannot join
- Less than 30 years of age
- Church members who did not complete the baseline questionnaire.
- Incarcerated or institutionalized people
- Non-English speakers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cancer Epidemiology in Seventh-day Adventists
The Adventist Health Study-2 is a long-term study, exploring the links between lifestyle, diet, and disease outcomes among Seventh-day Adventists. More than 96,000 church members from the U.S. and Canada are participating in the current study, AHS-2, conducted by researchers at the Loma Linda University School of Public Health.
Read the detailed description
The Adventist Health Study-2 (AHS-2) is a large national cohort of 96,000 Seventh-day Adventists in the U.S. and Canada. The study is searching for associations between diet and risk of common and medium frequency cancers (breast, prostate, colorectal, lung, uterus, pancreas, melanoma of skin). This cohort is unusual in that about half are vegetarian, many eat soy at Asian levels, and many have very low or absent dairy intake while others eat normal amounts of dairy. Thus observations on these people, many of whom have contrasting dietary habits, may provide insights about diet and cancer, so supporting dietary changes that could be readily adopted by many.
- Conditions
- Cancer, Breast, Cancer, Colorectal, Cancer, Prostate
- Keywords
- Seventh-day Adventists, vegetarian, mortality, cancer, dietary pattern, soy consumption, dairy consumption, plant-based
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Prostatic Neoplasms, Neoplasms
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 |
|---|---|---|
| Seventh-day Adventists | This is a prospective cohort study of 96,000 members of the Seventh-day Adventists Church in the United States and Canada age 30 and older at the time of enrollment who are proficient in English language. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident cases of breast cancer among subjects with documented dietary habits.
Incident cases of breast cancer as found by linkage with state cancer registries will allow calculation of hazard ratios comparing extreme quintiles of dietary intakes. The focus is on meats, soy, and dairy intakes.
Measured: Linkage with state cancer registries occurs periodically for 9 years, with first linkage at year 04 of study enrolment.
Secondary outcomes (1)
Incident cases of prostate cancer among subjects with documented dietary intakes.
Incident cases of prostate cancer as found by linkage with state cancer registries will allow calculation of hazard ratios comparing extreme quintiles of dietary intakes. The focus is on meats, soy, and dairy intakes.
Measured: Linkage with state cancer registries occurs periodically for 9 years, with first linkage at year 04 of study enrolment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start1 Feb 2002
- Primary completion31 Dec 2013
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cancer, BreastStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe 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
- Prospective
- Enrolment
- 96,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), World Cancer Research Fund International, Ardmore Institute of Health
- Responsible party
- Sponsor
- Investigators
- Gary E Fraser, MD,PhD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615599
- Sponsor's protocol ID
- 48134
- Other IDs
- U01CA152939, R01CA094594
- Acronym
- AHS-2
- Status last verified
- Jan 2026
- First submitted
- 29 Jun 2018
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers must write a proposal describing how the data will be used and submit it to the Adventist Health Study data sharing committee for approval.
Publications
Butler TL, Fraser GE, Beeson WL, Knutsen SF, Herring RP, Chan J, Sabate J, Montgomery S, Haddad E, Preston-Martin S, Bennett H, Jaceldo-Siegl K. Cohort profile: The Adventist Health Study-2 (AHS-2). Int J Epidemiol. 2008 Apr;37(2):260-5. doi: 10.1093/ije/dym165. Epub 2007 Aug 27. No abstract available.
PubMed 17726038Fraser GE, Jacobsen BK, Knutsen SF, Mashchak A, Lloren JI. Tomato consumption and intake of lycopene as predictors of the incidence of prostate cancer: the Adventist Health Study-2. Cancer Causes Control. 2020 Apr;31(4):341-351. doi: 10.1007/s10552-020-01279-z. Epub 2020 Feb 25.
PubMed 32100191
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Epidemiology in Seventh-day Adventists
- ClinicalTrials.gov ID
- NCT03615599
- Acronym / sponsor ID
- AHS-2 / 48134
- Conditions
- Cancer, Breast, Cancer, Colorectal, Cancer, Prostate
- Keywords
- Seventh-day Adventists, vegetarian, mortality, cancer, dietary pattern, soy consumption, dairy consumption, plant-based
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 96,000 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), World Cancer Research Fund International, Ardmore Institute of Health
- Study start
- 1 Feb 2002 (actual)
- Primary completion
- 31 Dec 2013 (actual)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Aug 2018 (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.
The Adventist Health Study-2 is a long-term study, exploring the links between lifestyle, diet, and disease outcomes among Seventh-day Adventists. More than 96,000 church members from the U.S. and Canada are participating in the current study, AHS-2, conducted by researchers at the Loma Linda University School of Public Health.
Detailed description
The Adventist Health Study-2 (AHS-2) is a large national cohort of 96,000 Seventh-day Adventists in the U.S. and Canada. The study is searching for associations between diet and risk of common and medium frequency cancers (breast, prostate, colorectal, lung, uterus, pancreas, melanoma of skin). This cohort is unusual in that about half are vegetarian, many eat soy at Asian levels, and many have very low or absent dairy intake while others eat normal amounts of dairy. Thus observations on these people, many of whom have contrasting dietary habits, may provide insights about diet and cancer, so supporting dietary changes that could be readily adopted by many.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Seventh-day Adventists | – | –This is a prospective cohort study of 96,000 members of the Seventh-day Adventists Church in the United States and Canada age 30 and older at the time of enrollment who are proficient in English language. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The sample includes Seventh-day Adventist church members living in the USA and Canada who are 30 years and older, and who are sufficiently fluent in English to complete the lengthy lifestyle questionnaire. The study population is about 65% female. Approximately 25% of the cohort are Black/African Americans . Other ethnic minorities (e.g. Asian, Hispanic) are at much lower percentages (3-4 %).
Key inclusion criteria (1 listed)
- Member of a Seventh-day Adventist church >30 years of age Ability to read English Live in the US or Canada
Key exclusion criteria (4 listed)
- Less than 30 years of age
- Church members who did not complete the baseline questionnaire.
- Incarcerated or institutionalized people
- Non-English speakers
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 cases of breast cancer among subjects with documented dietary habits.
Time frame: Linkage with state cancer registries occurs periodically for 9 years, with first linkage at year 04 of study enrolment.
Incident cases of breast cancer as found by linkage with state cancer registries will allow calculation of hazard ratios comparing extreme quintiles of dietary intakes. The focus is on meats, soy, and dairy intakes.
1 secondary outcome
Incident cases of prostate cancer among subjects with documented dietary intakes.
Time frame: Linkage with state cancer registries occurs periodically for 9 years, with first linkage at year 04 of study enrolment.
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 30 Jan 2026.
- Background: PubMed 17726038Butler TL, Fraser GE, Beeson WL, Knutsen SF, Herring RP, Chan J, Sabate J, Montgomery S, Haddad E, Preston-Martin S, Bennett H, Jaceldo-Siegl K. Cohort profile: The Adventist Health Study-2 (AHS-2). Int J Epidemiol. 2008 Apr;37(2):260-5. doi: 10.1093/ije/dym165. Epub 2007 Aug 27. No abstract available.
- Derived from this study: PubMed 32100191Fraser GE, Jacobsen BK, Knutsen SF, Mashchak A, Lloren JI. Tomato consumption and intake of lycopene as predictors of the incidence of prostate cancer: the Adventist Health Study-2. Cancer Causes Control. 2020 Apr;31(4):341-351. doi: 10.1007/s10552-020-01279-z. Epub 2020 Feb 25.
- Individual participant dataSharing planned: Yes. Researchers must write a proposal describing how the data will be used and submit it to the Adventist Health Study data sharing committee for approval.
Related trials for Cancer, Breast
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Gary E Fraser, MD,PhD principal investigator
Loma Linda University
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, Breast and Cancer, Colorectal, run by Loma Linda University 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 1 inclusion and 4 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 30 Jan 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 cases of breast cancer among subjects with documented dietary habits. (time frame: Linkage with state cancer registries occurs periodically for 9 years, with first linkage at year 04 of study enrolment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03615599, which also lists 2 linked publications.
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 30 Jan 2026.