Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07212491

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

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 (this does not apply to the brushings/biopsies only portion of the study for RST/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

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Other names: Non-Interventional Observational Study, Noninterventional (Observational) Study

Primary outcomes

  1. Sensitivity of deoxyribonucleic acid (DNA) markers

    Time frame: 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).

  2. Specificity of DNA markers

    Time frame: Baseline

    Will evaluate the specificity of DNA markers (methylated DNA markers ± aneuploidy) to distinguish between HGD/EAC and non-dysplastic BE.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Oct 8, 2025
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.