Minimally Invasive Molecular Approaches for the Detection of Barrett's Esophagus- High Grade Dysplasia and Esophageal Adenocarcinoma- Renewal Grant Aim 2 (The SOS6C Trial)

Not yet recruiting

• Conditions: Barrett Esophagus; Esophageal Adenocarcinoma

• Registration Number: NCT07212491
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-30
• Study First Submitted QC: 2025-09-30
• Last Update Submitted: 2025-09-30
• Study Start: 2025-10-01
• Study First Posted: 2025-10-08
• Last Update Posted: 2025-10-08
• Primary Completion: 2028-10-31
• Study Completion: 2028-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of deoxyribonucleic acid (DNA) markers	Baseline	Will evaluate the sensitivity of DNA makers (methylated DNA markers ± aneuploidy) to distinguish between high-grade dysplasia (HGD)/esophageal adenocarcinoma (EAC) and non-dysplastic Barrett's esophagus (BE).
Specificity of DNA markers	Baseline	Will evaluate the specificity of DNA markers (methylated DNA markers ± aneuploidy) to distinguish between HGD/EAC and non-dysplastic BE.

Trial Locations

Locations (3)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States