Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
Healthy Volunteers
NCT03961945

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

Led by Mayo Clinic · Updated on 2026-01-26

1550

Participants Needed

9

Research Sites

473 weeks

Total Duration

On this page

Sponsors

M

Mayo Clinic

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 90Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female ages 50 to 85
  • Patients with three or more risk factors for Barrett's Esophagus
  • Diagnosis of gastroesophageal reflux disease or use of reflux medications for at least 3 months in the last 5 years
  • Prior endoscopic diagnosis of erosive esophagitis
  • Body mass index (BMI) of 30 or higher
  • Subjects aged 18 to 90 with known or suspected Barrett's Esophagus
  • BE segment 1 cm or longer or suspected Barrett's Esophagus in medical records
  • Histology showing intestinal metaplasia with or without dysplasia or suspected Barrett's Esophagus
  • Undergoing clinically indicated endoscopy
  • Subjects without known history of Barrett's Esophagus undergoing diagnostic endoscopy
Not Eligible

You will not qualify if you...

  • History of esophageal adenocarcinoma or esophageal squamous carcinoma
  • Prior endoscopic ablation for Barrett's Esophagus
  • History of esophageal squamous dysplasia
  • Current treatment with oral anticoagulants including Warfarin or Coumadin
  • History of cirrhosis or esophageal/gastric varices
  • History of Barrett's Esophagus
  • Endoscopy within the last 5 years
  • Prior ablation therapies like photodynamic therapy, radiofrequency ablation, cryotherapy, or argon plasma coagulation
  • History of esophageal resection for carcinoma
  • Pregnant or lactating females
  • Inability to consent
  • Current uninvestigated swallowing difficulties
  • History of eosinophilic esophagitis or achalasia
  • Use of antiplatelet agents or oral thrombin/factor Xa inhibitors unless stopped 3 to 5 days before sponge procedure
  • History of bleeding disorders
  • Known foregut carcinoma within 5 years
  • Prior chemotherapy or radiation for mediastinal or esophageal cancer

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 9 locations

1

Mayo Clinic Arizona

Scottsdale, Arizona, United States, 85259

Completed

2

Mayo Clinic Jacksonville

Jacksonville, Florida, United States, 32224

Completed

3

Mayo Clinic Health Systems - Austin

Austin, Minnesota, United States, 55912

Actively Recruiting

4

Mayo Clinic Health Systems - Mankato

Mankato, Minnesota, United States, 56001

Completed

5

Mayo Clinic Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

6

Northwell Health

New Hyde Park, New York, United States, 11040

Completed

7

Baylor Scott & White Research Institute

Dallas, Texas, United States, 75246

Completed

8

Mayo Clinic Health System-Eau Claire

Eau Claire, Wisconsin, United States, 54701

Actively Recruiting

9

Mayo Clinic Health System-Franciscan Healthcare

La Crosse, Wisconsin, United States, 54601

Withdrawn

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Research Team

C

Clinical Trials Referral Office

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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