Barrett EsophagusNCT05133102
Longitudinal Oral Microbiome Sampling for BE
An observational study of Barrett Esophagus, run by Columbia University at 2 sites in United States.
Trial summary
This is a longitudinal cohort study to assess the impact of repeated sampling of an oral microbiome signature for Barrett's esophagus (BE). Potential participants will be identified through chart review of patients who have had an endoscopy in the past three years. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Barrett Esophagus
- What is being tested?
- Sample collection
- How many people
- 275 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Mar 2021to Aug 2027
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Enrollment will continue until a total of 250 subjects complete all three saliva specimen collections: * 50 BE patients * 200 controls The investigators anticipate that approximately 10% of subjects will not complete all three specimen collections and will be excluded from the primary outcome analyses. Thus, the investigators expect to enroll ~275 subjects to have 250 with three saliva specimen collections. There is no cap on enrollment per study site. The anticipated duration of enrollment is 2 years (24 months).
Who may be able to join
- Scheduled for an upper endoscopy or had upper endoscopy within past three years
- Eighteen years of age or older
- Capable of producing a saliva sample
- Able to give informed consent
- For BE patients only: Endoscopic evidence of Barrett's esophagus (at least 1 cm maximal BE length; i.e. Prague classification: any C, M≥1), and intestinal metaplasia present on esophageal biopsies
Who cannot join
- History of head and neck cancer or esophageal squamous cell or gastric cancer
- History of esophageal or gastric surgery
- Scheduled to undergo colonoscopy on the day of initial saliva collection
- Scheduled only for Endoscopic retrograde cholangiopancreatography (ERCP) or Endoscopy ultrasound (EUS) without accompanying standard upper endoscopy on the day of initial saliva collection
- For BE patients only: History of prior endoscopic therapy for BE except a history of prior Endoscopic mucosal resection (EMR) of focal lesions without subsequent ablative therapy is permitted
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Katharine Boyce, RN contact
United States2 sites, 2 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Joel H. Rubenstein, MD, jhr@med.umich.edu
Amy Liu, Liuyalie@med.umich.edu
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Julian Abrams, MD, 212-305-1909, ja660@cumc.columbia.edu
About this study
Official title: Repeated Sampling of the Oral Microbiome to Improve Detection of Barrett's Esophagus
This is a longitudinal cohort study to assess the impact of repeated sampling of an oral microbiome signature for Barrett's esophagus (BE). Potential participants will be identified through chart review of patients who have had an endoscopy in the past three years.
Read the detailed description
Saliva collection is non-invasive and can be performed in clinical and non-clinical settings. As such, saliva testing is a highly attractive method for diagnosing and/or monitoring disease. The investigators previously showed that the bacterial make-up ("microbiome") of saliva is highly distinct in patients with and without Barrett's esophagus (BE), a precursor to esophageal cancer that normally can only be diagnosed by undergoing an upper endoscopy. While the microbiome of saliva is felt to be relatively stable over time, it is unclear whether a microbiome signature for Barrett's esophagus is reproducible within individuals. Also, repeated testing of saliva may improve the ability to diagnose Barrett's esophagus.
- Conditions
- Barrett Esophagus
- Being tested
- Sample collection
- Keywords
- Saliva, Sampling, Oral Microbiome
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample collectionOther
Collection of saliva sample
| Study group | Role | What they receive |
|---|---|---|
| Control | Patients who have undergone an endoscopy within the last three years and have never been diagnosed with Barrett's esophagus. Receives: Other: Sample collection | |
| Barrett's Esophagus | Patients who have undergone an endoscopy within the last three years and have histologically confirmed Barrett's esophagus. BE segment must be M>1cm, and has not be treated with endoscopic eradication therapy (focal mucosal resection without subsequent eradication therapy is allowed). Receives: Other: Sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance characteristics of a microbiome-based classifier with repeated sampling
Using a classifier developed from 16S rRNA gene sequencing data, the investigators will calculate the area under the receiver operating curve (AUROC) and associated 95% confidence interval for a classifier with three repeated measures per subject.
Measured: 2 months
Intra-class correlation coefficients (ICC) by BE status
This will be measured to determine the degree of consistency of a microbiome-based classifier for each individual's salivary microbiome assessments (three total per subject).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start19 Mar 2021
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- More trials run by Columbia 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
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Julian A Abrams, MD, Columbia University
- Investigators
- Julian Abrams, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133102
- Sponsor's protocol ID
- AAAS2622
- Other IDs
- R01CA238433
- Status last verified
- May 2026
- First submitted
- 12 Nov 2021
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated Sampling of the Oral Microbiome to Improve Detection of Barrett's Esophagus
- ClinicalTrials.gov ID
- NCT05133102
- Acronym / sponsor ID
- AAAS2622
- Conditions
- Barrett Esophagus
- Keywords
- Saliva, Sampling, Oral Microbiome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- University of Michigan, National Cancer Institute (NCI)
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 24 Nov 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.
This is a longitudinal cohort study to assess the impact of repeated sampling of an oral microbiome signature for Barrett's esophagus (BE). Potential participants will be identified through chart review of patients who have had an endoscopy in the past three years.
Detailed description
Saliva collection is non-invasive and can be performed in clinical and non-clinical settings. As such, saliva testing is a highly attractive method for diagnosing and/or monitoring disease. The investigators previously showed that the bacterial make-up ("microbiome") of saliva is highly distinct in patients with and without Barrett's esophagus (BE), a precursor to esophageal cancer that normally can only be diagnosed by undergoing an upper endoscopy. While the microbiome of saliva is felt to be relatively stable over time, it is unclear whether a microbiome signature for Barrett's esophagus is reproducible within individuals. Also, repeated testing of saliva may improve the ability to diagnose Barrett's esophagus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: Sample collectionPatients who have undergone an endoscopy within the last three years and have never been diagnosed with Barrett's esophagus. |
| Barrett's Esophagus | – | Other: Sample collectionPatients who have undergone an endoscopy within the last three years and have histologically confirmed Barrett's esophagus. BE segment must be M>1cm, and has not be treated with endoscopic eradication therapy (focal mucosal resection without subsequent eradication therapy is allowed). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Enrollment will continue until a total of 250 subjects complete all three saliva specimen collections: * 50 BE patients * 200 controls The investigators anticipate that approximately 10% of subjects will not complete all three specimen collections and will be excluded from the primary outcome analyses. Thus, the investigators expect to enroll ~275 subjects to have 250 with three saliva specimen collections. There is no cap on enrollment per study site. The anticipated duration of enrollment is 2 years (24 months).
Key inclusion criteria (5 listed)
- Scheduled for an upper endoscopy or had upper endoscopy within past three years
- Eighteen years of age or older
- Capable of producing a saliva sample
- Able to give informed consent
- For BE patients only: Endoscopic evidence of Barrett's esophagus (at least 1 cm maximal BE length; i.e. Prague classification: any C, M≥1), and intestinal metaplasia present on esophageal biopsies
Key exclusion criteria (5 listed)
- History of head and neck cancer or esophageal squamous cell or gastric cancer
- History of esophageal or gastric surgery
- Scheduled to undergo colonoscopy on the day of initial saliva collection
- Scheduled only for Endoscopic retrograde cholangiopancreatography (ERCP) or Endoscopy ultrasound (EUS) without accompanying standard upper endoscopy on the day of initial saliva collection
- For BE patients only: History of prior endoscopic therapy for BE except a history of prior Endoscopic mucosal resection (EMR) of focal lesions without subsequent ablative therapy is permitted
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sample collectionCollection of saliva sample | Other | Barrett's Esophagus, Control |
Primary outcome
Performance characteristics of a microbiome-based classifier with repeated sampling
Time frame: 2 months
Using a classifier developed from 16S rRNA gene sequencing data, the investigators will calculate the area under the receiver operating curve (AUROC) and associated 95% confidence interval for a classifier with three repeated measures per subject.
Intra-class correlation coefficients (ICC) by BE status
Time frame: 2 months
This will be measured to determine the degree of consistency of a microbiome-based classifier for each individual's salivary microbiome assessments (three total per subject).
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 12 May 2026.
- Individual participant dataSharing planned: No
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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.
Katharine Boyce, RN contact
Julian Abrams, MD principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barrett Esophagus, run by Columbia University at 2 sites 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 5 inclusion and 5 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 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Julian Abrams, MD (212-305-1909, ja660@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance characteristics of a microbiome-based classifier with repeated sampling (time frame: 2 months). The study lists 2 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 12 May 2026.