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Non-endoscopic Screening and Surveillance in Patients with Barrett’s Esophagus

Trial Status: Active

This trial studies the development of non-endoscopic screening and surveillance procedures to assess the relationship between the microbiome (bacteria and other organisms that live inside the body) and tissue inflammation in patients with Barrett’s esophagus who are at risk for developing esophageal adenocarcinoma. A key factor in Barrett's esophagus and esophageal adenocarcinoma is chronic inflammation. Chronic inflammation can lead to an altered microbiome, a “dysbiosis” that can sustain the chronic inflammatory environment and cause broad changes in the tumor microenvironment (normal cells, molecules, and blood vessels that surround and feed a tumor cell). Understanding this tumor microenvironment may help in developing a non-endoscopic testing strategy based on pathogenic factors to identify those patients at highest risk for developing esophageal adenocarcinoma.

Inclusion Criteria

  • BE PATIENTS: History of histologically confirmed BE, defined as endoscopically-suspected BE with intestinal metaplasia with goblet cells on esophageal biopsies
  • BE PATIENTS: BE length M >= 2
  • BE PATIENTS: Taking proton pump inhibitors at least once daily for 3 months prior to enrollment
  • Subjects using mouthwash (antimicrobial or other) are permitted to enroll in the study. While use of an antimicrobial mouthwash may influence the oral and potentially esophageal microbiome, the effects of a mouthwash are unknown. Furthermore, exclusion of these subjects may limit our ability to enroll successfully and in a timely fashion. Subjects will be instructed not to use mouthwash for one week prior to the day of endoscopy, and prior mouthwash use will be assessed as a potential confounder in the analysis stage

Exclusion Criteria

  • 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 electronic medical record (EMR) of focal lesions without subsequent ablative therapy is permitted

Minnesota

Rochester
Mayo Clinic in Rochester
Status: ACTIVE
Contact: Kenneth K. Wang
Phone: 507-255-4631

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE
Contact: Julian Abrams

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: ACTIVE
Contact: Gary Falk
Phone: 215-615-4951

PRIMARY OBJECTIVES:

I. To assess the relationship between the microbiome and tissue inflammation in Barrett’s progression to esophageal adenocarcinoma (EAC).

II. To determine how bile acid composition impacts the microbiome and tissue inflammation in Barrett’s esophagus.

III. To develop a non-endoscopic, biologically-based screening and surveillance strategy for Barrett’s esophagus.

OUTLINE:

Patients undergo Aeonose breath test at fasting state, followed by saliva and blood sample collection, and tethered capsule sponge testing over 5 minutes. Patients then undergo upper endoscopic procedure to obtain tissue samples.

Trial Phase Phase NA

Trial Type Screening

Lead Organization
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center

Principal Investigator
Julian Abrams

  • Primary ID AAAQ8763
  • Secondary IDs NCI-2019-05758
  • Clinicaltrials.gov ID NCT03060642