Non-endoscopic Screening and Surveillance in Patients with Barrett’s Esophagus
- 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
- 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
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.
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
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
- Primary ID AAAQ8763
- Secondary IDs NCI-2019-05758
- Clinicaltrials.gov ID NCT03060642