The Microenvironment in Barrett's Esophagus

Overview

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 Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kenneth Wang, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Bryan Linn

(507)255-4631

Linn.Bryan@mayo.edu

Austin, Minn.

Mayo Clinic principal investigator

Eduardo Antpack Filho, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Bryan Linn

(507) 255-4631

Linn.Bryan@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20316801

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