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

Official record

Identifier

NCT07212491

Recruiting locations

country

United States

Interventions studied

Non-Interventional Study

Lead sponsor

Mayo Clinic

Target enrolment

450 participants

Study type

OBSERVATIONAL

Phase

Not provided in the official record

Status

Enrolling by invitation

First posted

Oct 8, 2025

Last updated on the registry

Sep 29, 2026

Age

18 Years – 90 Years

Sex

ALL

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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

Indexed under

Esophageal Cancer