Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT06071845

Conditions

Barrett Esophagus

Barretts Esophagus With Dysplasia

Barrett's Esophagus Without Dysplasia

Esophageal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Cytosponge Procedure

Endoscopic Assessment

Study Details

Brief summary:

This clinical trial evaluates the use of cytosponge, a minimally invasive collection device, for the detection of Barrett's esophagus (BE) in patients undergoing endoscopy. Non-endoscopic swallowable encapsulate sponge cell collection devices combined with markers for BE/esophageal adenocarcinoma (EAC) detection are a guideline-endorsed alternative to endoscopy for BE screening. The Oncoguard registered trademark Esophagus test (OGE) test uses esophageal cytology specimens collected with a minimally invasive, non-endoscopic, encapsulated sponge sampling device to identify BE/EAC biomarkers that indicate whether a patient should undergo diagnostic endoscopy. The OGE test is a simple and cost effective screening method that may lower barriers to widespread adoption of BE screening in at risk patients, resulting in increased and earlier detection of BE/EAC.

Conditions

Barrett Esophagus

Barretts Esophagus With Dysplasia

Barrett's Esophagus Without Dysplasia

Esophageal Adenocarcinoma

Study ID

NCT06071845

Start date

Oct 16, 2023

Status verified date

May, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subjects with known or suspected Barrett's esophagus (BE) (cases)

  • Patients between the ages of 18-90.
  • Patients with a BE segment ≥ 1cm in maximal extent endoscopically or suspected BE in medical record.
  • Histology showing evidence of intestinal metaplasia with or without presence of dysplasia or suspected BE in medical record.
  • Undergoing clinically indicated endoscopy.
  • Subjects without known history of BE (controls)

  • Undergoing clinically indicated diagnostic endoscopy

Exclusion Criteria:

  • For 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 current history of uninvestigated dysphagia.
  • History of eosinophilic esophagitis, achalasia.
  • Patients on oral anticoagulation including Coumadin, Warfarin.
  • Patients on antiplatelet agents including Clopidogrel, unless discontinued for three to five days prior to the Cytosponge procedure.
  • Patients on oral thrombin inhibitors including Dabigatran and oral factor Xa inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for three to five days prior to the Cytosponge procedure.
  • Patients with history of known esophageal or gastric varices or cirrhosis.
  • Patients with history of surgical esophageal resection for esophageal carcinoma.
  • 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.

Study Design

Enrollment

450 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Known or Suspected Barrett's Esophagus (Case Arm)

Investigators will follow Cytosponge Cell Collection Kit Instructions for Use to administer and retrieve the Cytosponge device.c. After the sponge is retrieved, it will then be placed in a vial of cell preservative solution (PN DD-13631, Exact Sciences, Madison, WI) and shipped to the Exact Sciences laboratory for further processing and subsequent analysis.

active comparator: No Known Barrett's Esophagus (Control Arm)

Participants will undergo a diagnostic clinically indicated sedated endoscopy with standard endoscopic equipment.

Interventions

Cytosponge Procedure

Investigators will follow the Cytosponge Cell Collection Kit Instructions for Use to administer and retrieve the Cytosponge device.

Endoscopic Assessment

Participants will undergo a diagnostic clinically indicated sedated endoscopy with standard endoscopic equipment.

Primary outcome measure

  • DNA yield from esophageal cytology samples collected with the Cytosponge device [ Time Frame: 12 months ]
  • Accuracy of the Oncoguard Esophagus (OGE) test [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Prasad Iyer, MD

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Herbert C. Wolfsen, MD

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Prasad G. Iyer, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 2, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-02.