Barrett EsophagusBETRNet2NCT03060642
The Microenvironment in Barrett's Esophagus
An observational study of Barrett Esophagus and Esophageal Adenocarcinoma, run by Columbia University at 3 sites in United States.
Trial summary
This study aims to elucidate the relationship between the microbiome, inflammation, and the microenvironment in Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC), with the end goal of developing a non-endoscopic testing strategy based on pathogenic factors to identify patients at highest risk for EAC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett Esophagus, Esophageal Adenocarcinoma
- What is being tested?
- Tethered capsule sponge and Electronic nose device
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 155 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Feb 2018to 30 Nov 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with or without Barrett's esophagus already scheduled for upper endoscopy.
Who may be able to join
- (for BE patients)
- History of histologically confirmed BE, defined as endoscopically-suspected BE with intestinal metaplasia with goblet cells on esophageal biopsies
- BE length M≥2
- Taking proton pump inhibitors at least once daily for 3 months prior to enrollment
- Age ≥18
Who cannot join
- History of gastric cancer or esophageal squamous cell cancer
- History of gastric or esophageal surgery
- Use of antibiotics or systemic immunosuppressants within three months prior to the date of endoscopy (intranasal and inhaled steroids are allowed)
- Known untreated esophageal stricture or uninvestigated dysphagia
- Inability to give informed consent
- (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
3 sites in 1 country.
United States3 sites
Columbia University Medical Center
New York, New York, 10032
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Application of the Microbiome and Microenvironment to Novel Non-Endoscopic Screening and Surveillance in Barrett's Esophagus
This study aims to elucidate the relationship between the microbiome, inflammation, and the microenvironment in Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC), with the end goal of developing a non-endoscopic testing strategy based on pathogenic factors to identify patients at highest risk for EAC. To accomplish this the investigators will enroll 100 patients with known BE (50 with dysplasia or EAC) and 50 subjects without BE undergoing upper endoscopy. Prior to endoscopy each subject will undergo three minimally invasive potential screening and surveillance tests: saliva (oral microbiome), breath test (exhaled volatile organic compounds), and tethered capsule sponge sampling (methylated DNA markers). The study will evaluate these novel tests in combination with clinical and anthropometric factors to describe an optimal strategy for BE screening and monitoring.
Read the detailed description
The investigators will perform a multi-center cross-sectional study of patients with Barrett's esophagus, with and without associated dysplasia or cancer, and controls without BE. Enrollment of controls will be stratified based on use of proton pump inhibitors (PPIs). The investigators plan to enroll an approximate total of 150 subjects:
100 BE patients (with or without associated dysplasia or cancer)
- 50 subjects with non-dysplastic BE
- 50 subjects with BE and dysplasia or EAC 50 controls
- 25 controls on PPIs (at least once daily)
- 25 controls not taking PPIs
Various tests will be performed and samples collected on the day of endoscopy. These tests include: saliva samples, electronic nose device testing, tethered capsule sponge testing, dietary questionnaires, and collection of blood and gastrointestinal biosamples. Analyses of this data and samples will then be performed to address the specific aims above.
- Conditions
- Barrett Esophagus, Esophageal Adenocarcinoma
- Being tested
- Tethered capsule sponge, Electronic nose device
- Keywords
- Microenvironment, Microbiome, Screening, Barrett Esophagus, Esophageal Adenocarcinoma
- 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.
Tethered capsule spongeDevice
Also called EsophaCap
Subjects swallow a tethered capsule sponge sampling device, which is then withdrawn through the mouth after an interval of 5 minutes.
Electronic nose deviceDevice
Also called Aeonose
Subjects breathe into the device, which then records an exhaled volatile organic compounds (VOC) signature.
| Study group | Role | What they receive |
|---|---|---|
| Barrett's esophagus | Barrett's esophagus, without or with dysplasia or adenocarcnoma Receives: Device: Tethered capsule sponge; Device: Electronic nose device | |
| Controls | Non-BE endoscopic controls Receives: Device: Tethered capsule sponge; Device: Electronic nose device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral and esophageal 16S rRNA gene sequencing
Oral and esophageal microbiome
Measured: 1 day
Secondary outcomes (2)
Esophageal tissue RNA-Seq
Esophageal tissue transcriptome
Measured: 1 day
Gastric aspirate mass spectrometry
Gastric aspirate bile acid composition
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Feb 2018
- Primary completion30 Apr 2021
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, University of Pennsylvania
- Responsible party
- Principal investigator, Julian A Abrams, MD, Columbia University
- Investigators
- Julian A. Abrams, MD, MS, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060642
- Sponsor's protocol ID
- AAAQ8763
- Other IDs
- NCI U54 CA163004-09
- Acronym
- BETRNet2
- Status last verified
- Apr 2024
- First submitted
- 2 Feb 2017
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Iyer PG, Slettedahl SW, Mahoney DW, Giakoumopoulos M, Olson MC, Krockenberger M, Taylor WR, Foote P, Berger C, Leggett C, Wu TT, Antpack E, Falk GW, Ginsberg GG, Abrams JA, Lightdale CJ, Ramirez F, Kahn A, Wolfsen H, Konda V, Trindade AJ, Kisiel JB. Algorithm Training and Testing for a Nonendoscopic Barrett's Esophagus Detection Test in Prospective Multicenter Cohorts. Clin Gastroenterol Hepatol. 2024 Aug;22(8):1596-1604.e4. doi: 10.1016/j.cgh.2024.03.003. Epub 2024 Mar 19.
PubMed 38513982
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the Microbiome and Microenvironment to Novel Non-Endoscopic Screening and Surveillance in Barrett's Esophagus
- ClinicalTrials.gov ID
- NCT03060642
- Acronym / sponsor ID
- BETRNet2 / AAAQ8763
- Conditions
- Barrett Esophagus, Esophageal Adenocarcinoma
- Keywords
- Microenvironment, Microbiome, Screening, Barrett Esophagus, Esophageal Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Mayo Clinic, University of Pennsylvania
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 23 Feb 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.
This study aims to elucidate the relationship between the microbiome, inflammation, and the microenvironment in Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC), with the end goal of developing a non-endoscopic testing strategy based on pathogenic factors to identify patients at highest risk for EAC. To accomplish this the investigators will enroll 100 patients with known BE (50 with dysplasia or EAC) and 50 subjects without BE undergoing upper endoscopy. Prior to endoscopy each subject will undergo three minimally invasive potential screening and surveillance tests: saliva (oral microbiome), breath test (exhaled volatile organic compounds), and tethered capsule sponge sampling (methylated DNA markers). The study will evaluate these novel tests in combination with clinical and anthropometric factors to describe an optimal strategy for BE screening and monitoring.
Detailed description
The investigators will perform a multi-center cross-sectional study of patients with Barrett's esophagus, with and without associated dysplasia or cancer, and controls without BE. Enrollment of controls will be stratified based on use of proton pump inhibitors (PPIs). The investigators plan to enroll an approximate total of 150 subjects:
100 BE patients (with or without associated dysplasia or cancer)
- 50 subjects with non-dysplastic BE
- 50 subjects with BE and dysplasia or EAC 50 controls
- 25 controls on PPIs (at least once daily)
- 25 controls not taking PPIs
Various tests will be performed and samples collected on the day of endoscopy. These tests include: saliva samples, electronic nose device testing, tethered capsule sponge testing, dietary questionnaires, and collection of blood and gastrointestinal biosamples. Analyses of this data and samples will then be performed to address the specific aims above.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Barrett's esophagus | – | Device: Tethered capsule sponge, Device: Electronic nose deviceBarrett's esophagus, without or with dysplasia or adenocarcnoma |
| Controls | – | Device: Tethered capsule sponge, Device: Electronic nose deviceNon-BE endoscopic controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with or without Barrett's esophagus already scheduled for upper endoscopy.
Key inclusion criteria (5 listed)
- (for BE patients)
- History of histologically confirmed BE, defined as endoscopically-suspected BE with intestinal metaplasia with goblet cells on esophageal biopsies
- BE length M≥2
- Taking proton pump inhibitors at least once daily for 3 months prior to enrollment
- Age ≥18
Key exclusion criteria (6 listed)
- History of gastric cancer or esophageal squamous cell cancer
- History of gastric or esophageal surgery
- Use of antibiotics or systemic immunosuppressants within three months prior to the date of endoscopy (intranasal and inhaled steroids are allowed)
- Known untreated esophageal stricture or uninvestigated dysphagia
- Inability to give informed consent
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 |
|---|---|---|
| Tethered capsule spongeAlso: EsophaCapSubjects swallow a tethered capsule sponge sampling device, which is then withdrawn through the mouth after an interval of 5 minutes. | Device | Barrett's esophagus, Controls |
| Electronic nose deviceAlso: AeonoseSubjects breathe into the device, which then records an exhaled volatile organic compounds (VOC) signature. | Device | Barrett's esophagus, Controls |
Primary outcome
Oral and esophageal 16S rRNA gene sequencing
Time frame: 1 day
Oral and esophageal microbiome
2 secondary outcomes
Esophageal tissue RNA-Seq
Time frame: 1 day
Gastric aspirate mass spectrometry
Time frame: 1 day
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 5 Apr 2024.
- Derived from this study: PubMed 38513982Iyer PG, Slettedahl SW, Mahoney DW, Giakoumopoulos M, Olson MC, Krockenberger M, Taylor WR, Foote P, Berger C, Leggett C, Wu TT, Antpack E, Falk GW, Ginsberg GG, Abrams JA, Lightdale CJ, Ramirez F, Kahn A, Wolfsen H, Konda V, Trindade AJ, Kisiel JB. Algorithm Training and Testing for a Nonendoscopic Barrett's Esophagus Detection Test in Prospective Multicenter Cohorts. Clin Gastroenterol Hepatol. 2024 Aug;22(8):1596-1604.e4. doi: 10.1016/j.cgh.2024.03.003. Epub 2024 Mar 19.
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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 A. Abrams, MD, MS principal investigator
Columbia University
3 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 3 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 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 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Oral and esophageal 16S rRNA gene sequencing (time frame: 1 day). 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 NCT03060642, which also lists 1 linked publication.
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 5 Apr 2024.