CancerNCT03293758
Food and Microbiome Longitudinal Investigation (FAMiLI)
An observational study of Cancer and Cardiovascular Diseases, run by NYU Langone Health at 1 site in United States.
Trial summary
The NYU Human Microbiome Study Cohort is designed to improve understanding of the role of human microbiome in health and disease. This study will serve as a critical NYU biorepository resource for research on human genetics and the microbiome in health and disease Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Cardiovascular Diseases
- How many people
- 16,000 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2016to 31 Dec 2034
- How long will I take part?
- 10 Years
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects in the United States identified at NYU clinics, community organizations, and online participant databases.
Who may be able to join
- Age > 40
Who cannot join
- Use of long term antibiotics.
- Pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
New York University School of Medicine
New York, New York, 10016
Dia Beggs, 646-501-3396, dia.beggs@nyulangone.org
Jiyoung Ahn, PhD
About this study
The NYU Human Microbiome Study Cohort is designed to improve understanding of the role of human microbiome in health and disease. This study will serve as a critical NYU biorepository resource for research on human genetics and the microbiome in health and disease
- Conditions
- Cancer, Cardiovascular Diseases
- Medical subject headings
- Neoplasms, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic
sex, race, education, oral health status, lifestyle, medical history, anthropometry, and medication use will be collected using the baseline questionnaire at enrolment. The collected information will provide risk stratification information for statistical control in studies of colorectal tumors and other major chronic diseases.
Measured: 5 Years
Secondary outcomes (1)
Differences in human microbiota between subjects with colorectal adenoma or colorectal cancer and those without.
Pairwise alignment and clustering of sequences into operational taxonomic units (OTUs)
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start16 May 2016
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2034 (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 NYU Langone HealthThe 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
- 16,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jiyoung Ahn, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293758
- Sponsor's protocol ID
- 12-00855
- Other IDs
- R21CA183887
- Status last verified
- Feb 2026
- First submitted
- 22 Sep 2017
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food and Microbiome Longitudinal Investigation (FAMiLI)
- ClinicalTrials.gov ID
- NCT03293758
- Acronym / sponsor ID
- 12-00855
- Conditions
- Cancer, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 16,000 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 May 2016 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 26 Sep 2017 (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 NYU Human Microbiome Study Cohort is designed to improve understanding of the role of human microbiome in health and disease. This study will serve as a critical NYU biorepository resource for research on human genetics and the microbiome in health and disease
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects in the United States identified at NYU clinics, community organizations, and online participant databases.
Key inclusion criteria (1 listed)
- Age > 40
Key exclusion criteria (2 listed)
- Use of long term antibiotics.
- Pregnant
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
Demographic
Time frame: 5 Years
sex, race, education, oral health status, lifestyle, medical history, anthropometry, and medication use will be collected using the baseline questionnaire at enrolment. The collected information will provide risk stratification information for statistical control in studies of colorectal tumors and other major chronic diseases.
1 secondary outcome
Differences in human microbiota between subjects with colorectal adenoma or colorectal cancer and those without.
Time frame: 5 Years
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 Feb 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.
Jiyoung Ahn, PhD principal investigator
NYU Langone Health
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 Cardiovascular Diseases, run by NYU Langone Health 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 2 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: looking for participants now, as of the sponsor's last update on 25 Feb 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?
Contact Zelle Halloran (646-501-3673, Zelle.Halloran@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic (time frame: 5 Years). 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 Feb 2026.