The Microenvironment in Barrett's Esophagus
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-000574
- Austin, Minnesota: 17-000574
NCT ID: NCT03060642
Sponsor Protocol Number: AAAQ8763
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
(for BE patients)
- History of histologically confirmed BE, defined as endoscopically-suspected BE with intestinal metaplasia with goblet cells on esophageal biopsies.
- History of histologically confirmed Adenocarcinoma for Sub-aim 1 c.
- Clinically able to tolerate an endoscopy and biopsies.
- BE length M ≥ 2.
- Taking proton pump inhibitors at least once daily for 3 months prior to enrollment.
- Age ≥ 18 years old.
Exclusion Criteria:
- History of gastric cancer.
- Any prior chemotherapy for esophageal 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 EMR of focal lesions without subsequent ablative therapy is permitted.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Cadman Leggett, M.D. |
Closed for enrollment |
|
Austin, Minn.
Mayo Clinic principal investigator Eduardo Antpack Filho, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available