Barrett EsophagusNCT05524844
The Microbiome, Bile Acids, and Notch in Barrett's Esophagus (BE)
An observational study of Barrett Esophagus and Esophageal Adenocarcinoma, run by Columbia University at 2 sites in United States.
Trial summary
The purpose of this study is to prospectively collect and analyze clinical data and biospecimens from a cohort of 100 patients without BE (20), with non-dysplastic BE (40), or with BE and high grade dysplasia (HGD) or EAC (40). 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, Esophageal Adenocarcinoma
- What is being tested?
- Sample Collection, Endoscopy results and Dietary questionnaire
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Feb 2021to 1 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Study population will be based on the population of BE and EAC as well as the demographics of those who undergo upper endoscopy for other indications (the control population) at Columbia and Cornell, together with data drawn from numerous prior studies in our BE population.
Who may be able to join
- All subjects:
- Scheduled for an upper endoscopy
- Taking stable dose of a proton pump inhibitor at least once daily for 1 months prior to enrollment
- Eighteen years of age or older
- Able to give informed consent
- Barrett's esophagus subjects only:
- Histologically confirmed BE (defined as endoscopically- suspected BE with intestinal metaplasia with goblet cells on esophageal biopsies)
- Maximal BE length ≥ 2 cm (Prague criteria: any C, M≥2)
Who cannot join
- All subjects:
- History of head and neck cancer or esophageal or gastric cancer (except esophageal intramucosal adenocarcinoma)
- History of esophageal or gastric surgery
- Use of antibiotics or immunosuppressants within 1 month prior to endoscopy
- Barrett's esophagus subjects only:
- History of prior endoscopic therapy for BE, except a history of prior endoscopic mucosal resection (EMR) of focal lesions withoutsubsequent ablative therapy is permitted
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Columbia University Irving Medical Center
New York, New York, 10032
Weill Cornell Medical Center
New York, New York, 10065
About this study
Official title: The Role of the Microbiome and Notch Signaling in Esophageal Adenocarcinoma
The purpose of this study is to prospectively collect and analyze clinical data and biospecimens from a cohort of 100 patients without BE (20), with non-dysplastic BE (40), or with BE and high grade dysplasia (HGD) or EAC (40). The investigators will enroll 80 patients scheduled for upper endoscopy for clinical purposes, with a history of histologically confirmed BE (2 cm length); 40 with no history of dysplasia, and 40 with HGD or EAC. The investigators will also enroll 20 non-BE controls undergoing endoscopy for any indication who are on stable dose proton-pump inhibitors (PPI) for the past month. PPI therapy is standard of care for BE patients.
Read the detailed description
The incidence of esophageal adenocarcinoma (EAC) has risen 10-fold over the past half century and continues to have a dismal prognosis. Known risk factors for EAC do not adequately explain these incidence trends; the rise in EAC cases began a decade before increases in the prevalence of both gastro-esophageal reflux disease and obesity. Over the past 50+ years, dramatic changes in the bacterial composition (or microbiome) of the upper gastrointestinal tract have also occurred. While prior work has shown correlations between the microbiome, BE, and EAC, there is a critical knowledge gap on mechanisms by which bacteria interact with the esophagus and potentially promote cancer. The investigators hypothesize that increased levels of the certain bile acids in gastroesophageal reflux fluid cause changes that lead to increased interaction between bacteria and the esophagus, which may promote the development of esophageal adenocarcinoma (EAC). The investigators will carry out a case-control study of patients with and without BE, dysplasia, or EAC. The investigators will focus on deoxycholic acid in gastro-esophageal refluxate and its association with Notch signaling in tissue and bacterial composition. The microbiome represents a novel and potentially modifiable risk factor for the development of BE and EAC. Elucidation of microbiome features and mechanisms that promote the development of EAC is a critical step that will lead to subsequent trials of antibiotics, probiotics, and other interventions targeted to altering the microbiome, with the goal of lowering the risk of this highly lethal malignancy.
- Conditions
- Barrett Esophagus, Esophageal Adenocarcinoma
- Being tested
- Sample Collection, Endoscopy results, Dietary questionnaire
- Keywords
- Saliva, Microbiome
- Medical subject headings
- Barrett Esophagus, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample CollectionOther
Saliva, gastric aspirate, and esophageal brushings and biopsies.
Endoscopy resultsOther
Results from standard of care endoscopy (scheduled separate of study)
Dietary questionnaireOther
Diet History Questionnaire (II)
| Study group | Role | What they receive |
|---|---|---|
| Control | Non-BE controls undergoing endoscopy for any indication who are on stable dose Proton Pump Inhibitors for the past month. Receives: Other: Sample Collection; Other: Endoscopy results; Other: Dietary questionnaire | |
| Barrett's Esophagus | Patients scheduled for upper endoscopy for clinical purposes, with a history of histologically confirmed Barrett's esophagus (2 cm length); 40 with no history of dysplasia, and 40 with high grade dysplasia or esophageal adenocarcinoma. Receives: Other: Sample Collection; Other: Endoscopy results; Other: Dietary questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Deoxycholic Acid (DCA)
To determine whether refluxate deoxycholic acid (DCA) is associated with increased Notch signaling in the development of esophageal adenocarcinoma (EAC), the investigators will calculate Pearson's correlation coefficients to assess within individual correlations between DCA and NOTCH3 gene expression.
Measured: 2 years
Correlation between Enterobacteriaceae (from 16S) and NOTCH3 expression in BE tissue.
The within-individual correlation will be calculated.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start9 Feb 2021
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- 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
- NCT05524844
- Sponsor's protocol ID
- AAAT2456
- Other IDs
- R01CA255298
- Status last verified
- May 2025
- First submitted
- 30 Aug 2022
- Last updated
- 11 May 2025
- 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 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Microbiome and Notch Signaling in Esophageal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05524844
- Acronym / sponsor ID
- AAAT2456
- Conditions
- Barrett Esophagus, Esophageal Adenocarcinoma
- Keywords
- Saliva, Microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University, National Cancer Institute (NCI)
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 1 Sep 2022 (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 purpose of this study is to prospectively collect and analyze clinical data and biospecimens from a cohort of 100 patients without BE (20), with non-dysplastic BE (40), or with BE and high grade dysplasia (HGD) or EAC (40). The investigators will enroll 80 patients scheduled for upper endoscopy for clinical purposes, with a history of histologically confirmed BE (2 cm length); 40 with no history of dysplasia, and 40 with HGD or EAC. The investigators will also enroll 20 non-BE controls undergoing endoscopy for any indication who are on stable dose proton-pump inhibitors (PPI) for the past month. PPI therapy is standard of care for BE patients.
Detailed description
The incidence of esophageal adenocarcinoma (EAC) has risen 10-fold over the past half century and continues to have a dismal prognosis. Known risk factors for EAC do not adequately explain these incidence trends; the rise in EAC cases began a decade before increases in the prevalence of both gastro-esophageal reflux disease and obesity. Over the past 50+ years, dramatic changes in the bacterial composition (or microbiome) of the upper gastrointestinal tract have also occurred. While prior work has shown correlations between the microbiome, BE, and EAC, there is a critical knowledge gap on mechanisms by which bacteria interact with the esophagus and potentially promote cancer. The investigators hypothesize that increased levels of the certain bile acids in gastroesophageal reflux fluid cause changes that lead to increased interaction between bacteria and the esophagus, which may promote the development of esophageal adenocarcinoma (EAC). The investigators will carry out a case-control study of patients with and without BE, dysplasia, or EAC. The investigators will focus on deoxycholic acid in gastro-esophageal refluxate and its association with Notch signaling in tissue and bacterial composition. The microbiome represents a novel and potentially modifiable risk factor for the development of BE and EAC. Elucidation of microbiome features and mechanisms that promote the development of EAC is a critical step that will lead to subsequent trials of antibiotics, probiotics, and other interventions targeted to altering the microbiome, with the goal of lowering the risk of this highly lethal malignancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: Sample Collection, Other: Endoscopy results, Other: Dietary questionnaireNon-BE controls undergoing endoscopy for any indication who are on stable dose Proton Pump Inhibitors for the past month. |
| Barrett's Esophagus | – | Other: Sample Collection, Other: Endoscopy results, Other: Dietary questionnairePatients scheduled for upper endoscopy for clinical purposes, with a history of histologically confirmed Barrett's esophagus (2 cm length); 40 with no history of dysplasia, and 40 with high grade dysplasia or esophageal adenocarcinoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will be based on the population of BE and EAC as well as the demographics of those who undergo upper endoscopy for other indications (the control population) at Columbia and Cornell, together with data drawn from numerous prior studies in our BE population.
Key inclusion criteria (8 listed)
- Scheduled for an upper endoscopy
- Taking stable dose of a proton pump inhibitor at least once daily for 1 months prior to enrollment
- Eighteen years of age or older
- Able to give informed consent
- Histologically confirmed BE (defined as endoscopically- suspected BE with intestinal metaplasia with goblet cells on esophageal biopsies)
Key exclusion criteria (6 listed)
- History of head and neck cancer or esophageal or gastric cancer (except esophageal intramucosal adenocarcinoma)
- History of esophageal or gastric surgery
- Use of antibiotics or immunosuppressants within 1 month prior to endoscopy
- History of prior endoscopic therapy for BE, except a history of prior endoscopic mucosal resection (EMR) of focal lesions withoutsubsequent 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 CollectionSaliva, gastric aspirate, and esophageal brushings and biopsies. | Other | Barrett's Esophagus, Control |
| Endoscopy resultsResults from standard of care endoscopy (scheduled separate of study) | Other | Barrett's Esophagus, Control |
| Dietary questionnaireDiet History Questionnaire (II) | Other | Barrett's Esophagus, Control |
Primary outcome
Concentration of Deoxycholic Acid (DCA)
Time frame: 2 years
To determine whether refluxate deoxycholic acid (DCA) is associated with increased Notch signaling in the development of esophageal adenocarcinoma (EAC), the investigators will calculate Pearson's correlation coefficients to assess within individual correlations between DCA and NOTCH3 gene expression.
Correlation between Enterobacteriaceae (from 16S) and NOTCH3 expression in BE tissue.
Time frame: 2 years
The within-individual correlation will be calculated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- 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. This study is not recruiting at the moment.
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 and Esophageal Adenocarcinoma, 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 8 inclusion and 6 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: finished, as of the sponsor's last update on 11 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Concentration of Deoxycholic Acid (DCA) (time frame: 2 years). 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 11 May 2025.