Actively Recruiting
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
Eligibility Criteria
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
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
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
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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