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

Mayo Clinic

Status: Invitation-only

Conditions: Barrett Esophagus; Esophageal Adenocarcinoma

Treatments: Other: Non-Interventional Study

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT07212491

25-000761 (Other Identifier)

SOS6C (Other Identifier)

R01CA241164 (U.S. NIH Grant/Contract)

NCI-2025-06712 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 1 patient group

Observational

Description:

Patients undergo capsule sponge assessment over 5-10 minutes prior to standard of care endoscopy. Patients also undergo biopsy and esophageal brushing sample collection and complete questionnaires on study.

Treatment:

Other: Non-Interventional Study