Status:
ENROLLING_BY_INVITATION
Minimally Invasive Molecular Approaches for the Detection of Barrett's Esophagus- High Grade Dysplasia and Esophageal Adenocarcinoma
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Barrett Esophagus
Esophageal Adenocarcinoma
Eligibility:
All Genders
18-90 years
Brief Summary
This study explores the use of a minimally invasive screening tool (a sponge on a string device) to detect Barrett's esophagus and esophageal adenocarcinoma and to develop a laboratory test for the de...
Eligibility Criteria
Inclusion
- Patient between the ages 18 - 90
- Patients with a BE segment \>= 1cm in maximal extent endoscopically
- Histology showing evidence of intestinal metaplasia with or without presence of dysplasia
- Undergoing clinically indicated endoscopy
Exclusion
- Patients with a prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with a history of endoscopic mucosal resection alone will not be excluded
- Patients with a history of esophageal or gastric resection for esophageal or gastric carcinoma
- 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 a current history of uninvestigated dysphagia (this does not apply to the brushings only portion of the study)
- History of eosinophilic esophagitis, achalasia
- Patients on oral anticoagulation including Coumadin, and warfarin, unless discontinued for five days prior to the sponge procedure
- Patients on antiplatelet agents including clopidogrel, unless discontinued for five days prior to the sponge procedure
- Patients on oral thrombin inhibitors including dabigatran and oral factor X an inhibitor such as rivaroxaban, apixaban, and edoxaban, unless discontinued for five days prior to the sponge procedure
- Patients with a history of known varices or cirrhosis
- Patients with a history of esophageal or gastric resection
- Patients with congenital or acquired bleeding diatheses
- Patients with a history of esophageal squamous dysplasia
Key Trial Info
Start Date :
November 17 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2028
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07212491
Start Date
November 17 2025
End Date
October 31 2028
Last Update
December 31 2025
Active Locations (3)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
3
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905