Minimally Invasive Molecular Approaches for the Detection of Barrett's Esophagus- High Grade Dysplasia and Esophageal Adenocarcinoma
Enrolling by invitation
Conditions studied: Barrett Esophagus, Esophageal Adenocarcinoma
In brief
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 detection of Barrett's esophagus-high grade dysplasia and esophageal adenocarcinoma.
Key facts
- Study ID
- NCT07212491
- Run by
- Mayo Clinic
- People needed
- 450
- Starts
- 2025-11-17
- Expected to finish
- 2030-07-31
- Last updated by the study team
- 2026-05-06
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 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/biopsies only portion of the study for RST/ARZ sites only)
- History of eosinophilic esophagitis or achalasia
- Patients on oral anticoagulation including Coumadin, and warfarin, unless discontinued for thee to five days prior to the sponge procedure. (This does not apply to the brushing/biopsy only portion of the study for RST/ARZ sites only)
- Patients on antiplatelet agents including clopidogrel, unless discontinued for three to five days prior to the sponge procedure. (This does not apply to the brushing/biopsy only portion of the study for RST/ARZ sites only)
- Patients on oral thrombin inhibitors including dabigatran and oral factor X an inhibitor such as rivaroxaban, apixaban, and edoxaban, unless discontinued for three to five days prior to the sponge procedure. (This does not apply to the brushing/biopsy only portion of the study for RST/ARZ sites only)
- Patients with a history of known esophageal or gastric 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
- 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
- Patients with Familial Adenomatous Polyposis (FAP) or Lynch Syndrome
Where it is running
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States
- Mayo Clinic in Florida — Jacksonville, Florida, United States
- Mayo Clinic in Rochester — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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