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
N/A
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
Researchers are evaluating a minimally invasive molecular method to detect Barrett's Esophagus and esophageal adenocarcinoma using a sponge capsule device. The study aims to assess the accuracy of this device in screening people with and without chronic gastroesophageal reflux disease, including those at risk or with a diagnosis of Barrett's Esophagus. This approach focuses on detecting methylated DNA markers from esophageal cells collected by the device. Participants will swallow the sponge capsule, which collects esophageal cells for analysis. The procedure will be performed by trained non-physicians like nurses. Study groups include people with gastroesophageal reflux or other risk factors, those diagnosed with Barrett's Esophagus scheduled for upper endoscopy, and those without Barrett's Esophagus also scheduled for endoscopy. Some participants will also undergo biopsies and brushings during endoscopy. During the study, participants will complete questionnaires and undergo the sponge capsule procedure, and those undergoing endoscopy will have additional tissue sampling for comparison. Researchers will measure the sensitivity and specificity of the device to detect Barrett's Esophagus and dysplasia over five years. Safety, tolerability, and predictive value of the sponge capsule procedure will also be monitored. The study duration includes follow-up assessments over five years to evaluate outcomes.
CONDITIONS
Brief 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 years
- Patients with three or more risk factors for Barrett's Esophagus
- Diagnosis of gastroesophageal reflux disease or use of reflux medications for 3 or more months in the last 5 years
- Prior endoscopic diagnosis of erosive esophagitis
- Body mass index (BMI) of 30 or higher
- Subjects with known or suspected Barrett's Esophagus aged 18 to 90 years
- Barrett's Esophagus segment of 1 cm or more in maximal extent or suspected Barrett's Esophagus in medical record
- Histology showing intestinal metaplasia with or without dysplasia or suspected Barrett's Esophagus in medical record
- Undergoing clinically indicated endoscopy
- Subjects without known Barrett's Esophagus undergoing clinically indicated diagnostic endoscopy
You will not qualify if you...
- Previous esophageal adenocarcinoma or esophageal squamous carcinoma
- Prior endoscopic ablation for Barrett's Esophagus
- Esophageal squamous dysplasia
- Current treatment with oral anticoagulants including Warfarin or Coumadin
- History of cirrhosis or esophageal/gastric varices
- History of Barrett's Esophagus (for screening aims)
- Prior endoscopy within the last 5 years (for screening aims)
- Prior ablation therapies such as photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation (for known Barrett's Esophagus subjects)
- History of esophageal resection for esophageal carcinoma
- Pregnant or lactating females
- Unable to consent
- Current history of uninvestigated dysphagia (except for biopsy/brushings only)
- History of eosinophilic esophagitis or achalasia
- Use of antiplatelet agents unless stopped 3 to 5 days before sponge procedure
- Use of oral thrombin inhibitors or factor Xa inhibitors unless stopped 3 to 5 days before sponge procedure
- Congenital or acquired bleeding disorders
- Known carcinoma of the foregut within 5 years prior to enrollment
- Received chemotherapy or radiation for mediastinal or esophageal cancer within 5 years prior to enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure
Participants swallow a sponge capsule device to collect esophageal cells. This procedure is performed by a nurse and is used to detect Barrett's Esophagus and esophageal adenocarcinoma using molecular markers.
1 visit (in-person)
Duration - Single procedure
Participants scheduled for upper endoscopy may also undergo endoscopic biopsies and brushings of the esophagus as part of the diagnostic evaluation.
1 visit (in-person)
Duration - Up to 5 years
Participants are monitored over up to 5 years to assess diagnostic outcomes and safety measures related to the sponge capsule procedure.
Follow-up visits as determined by clinical care
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here