RecruitingNot ApplicableNCT03961945

Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma


Sponsor

Mayo Clinic

Enrollment

1,550 participants

Start Date

Jul 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This study will evaluate if the sponge capsule device can accurately detect the presence of Barrett's Esophagus and prevalent dysplasia/adenocarcinoma detection, in a screening population, with and without chronic gastroesophageal reflux disease.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria14

  • Male and female ages 50-85
  • Patients who have three or more risk factors for Barrett's Esophagus.
  • Gastroesophageal reflux disease defined by:
  • Diagnosis
  • Use of one of the following drugs \>= 3 months over the last 5 years: omeprazole, esomeprazole, pantoprazole, rabeprazole, dexlansoprazole, lansoprazole, ranitidine, famotidine, cimetidine
  • prior endoscopic diagnosis of erosive esophagitis
  • Body mass index (BMI) \>= 30
  • Subjects with known or suspected BE (cases).
  • Patient between the ages 18 - 90.
  • Patients with a BE segment ≥ 1cm in maximal extent endoscopically or suspected BE in medical record.
  • Histology showing evidence of intestinal metaplasia with or without presence of dysplasia or suspected BE in medical record.
  • Undergoing clinically indicated endoscopy.
  • Subjects without known history of BE (controls).
  • Undergoing clinically indicated diagnostic endoscopy.

Exclusion Criteria27

  • Previous history of:
  • esophageal adenocarcinoma/cancer
  • esophageal squamous carcinoma
  • endoscopic ablation for Barrett's esophagus
  • esophageal squamous dysplasia
  • Current treatment with oral anticoagulation including Warfarin, Coumadin
  • History of cirrhosis
  • History of esophageal/gastric varices
  • History of Barrett's esophagus
  • Prior endoscopy in the last 5 years
  • Subjects with known BE.
  • Patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with history of endoscopic mucosal resection (EMR)/endoscopic submucosal dissection (ESD) alone will not be excluded.
  • Patients with history of esophageal resection for esophageal carcinoma.
  • For subjects with or without known evidence of BE (on history or review of medical records):
  • Pregnant or lactating females.
  • Patients who are unable to consent.
  • Patients with current history of uninvestigated dysphagia (this does not apply to the brushings/biopsies only portion of the study).
  • History of eosinophilic esophagitis, achalasia.
  • Patients on oral anticoagulation including Coumadin, Warfarin (this does not apply to the brushings/biopsies only portion of the study).
  • Patients on antiplatelet agents including Clopidogrel, unless discontinued for three to five days prior to the sponge procedure.
  • Patients on oral thrombin inhibitors including Dabigatran and oral factor Xa inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for three to five days prior to the sponge procedure.
  • Patients with history of known esophageal or gastric varices or cirrhosis.
  • Patients with history of surgical esophageal resection for esophageal carcinoma.
  • Patients with congenital or acquired bleeding diatheses.
  • Patients with a history of esophageal squamous dysplasia.
  • Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.
  • Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer.

Interventions

DEVICESponge Capsule

Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge.


Locations(9)

Mayo Clinic Arizona

Scottsdale, Arizona, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Mayo Clinic Health Systems - Austin

Austin, Minnesota, United States

Mayo Clinic Health Systems - Mankato

Mankato, Minnesota, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Northwell Health

New Hyde Park, New York, United States

Baylor Scott & White Research Institute

Dallas, Texas, United States

Mayo Clinic Health System-Eau Claire

Eau Claire, Wisconsin, United States

Mayo Clinic Health System-Franciscan Healthcare

La Crosse, Wisconsin, United States

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NCT03961945


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