Minimally Invasive Molecular Approaches for the Detection of Barrett's Esophagus- High Grade Dysp… (NCT07212491) | Clinical Trial Compass
By InvitationNot Applicable
Minimally Invasive Molecular Approaches for the Detection of Barrett's Esophagus- High Grade Dysplasia and Esophageal Adenocarcinoma
United States450 participantsStarted 2025-11-17
Plain-language 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 detection of Barrett's esophagus-high grade dysplasia and esophageal adenocarcinoma.
Who can participate
Age range18 Years – 90 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 f…
What they're measuring
1
Sensitivity of deoxyribonucleic acid (DNA) markers