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Enrolling By Invitation
NCT07212491
Minimally Invasive Molecular Approaches for the Detection of Barrett's Esophagus- High Grade Dysplasia and Esophageal Adenocarcinoma
Conditions: Barrett Esophagus, Esophageal Adenocarcinoma
Sex: All
Ages: 18 Years – 90 Years
Healthy volunteers: No
Enrollment: 450
Sponsor: Mayo Clinic
Location: Mayo Clinic in Arizona Scottsdale Arizona
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.
Eligibility Criteria
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 \[does not apply to the brushings/biopsies only portion of the study for Mayo Clinic in Rochester (RST)/Mayo Clinic in Arizona (ARZ) sites only\]
* 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
Source: ClinicalTrials.gov (NCT07212491). StuddyBuddy aggregates publicly available trial information.