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By invitation only NCT07212491

Minimally Invasive Molecular Approaches for the Detection of Barrett's Esophagus- High Grade Dysplasia and Esophageal Adenocarcinoma

Conditions: Barrett Esophagus Esophageal Adenocarcinoma

Sponsor: Mayo Clinic

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Overview
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
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 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
Interventions
Non-Interventional Study
OTHER
Locations 3
United States (3)
Mayo Clinic in Florida
Jacksonville , Florida
Mayo Clinic in Rochester
Rochester , Minnesota
Mayo Clinic in Arizona
Scottsdale , Arizona
Technical details
Status
By invitation only
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
90 Years
Healthy volunteers
No
Start date
17.11.2025
Completion date
31.07.2030
Registry ID
NCT07212491
Source
clinicaltrials.gov
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