Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples

NCT06071845 | Recruiting DMC FDA Device

• 2 other identifiers: 22-010506NCI-2023-07131
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (2)

• DNA yield from esophageal cytology samples collected with the Cytosponge device

  DNA concentration from samples collected with the Cytosponge device will be compared with DNA concentration previously observed from samples collected with the EsophaCap device on another study. The DNA concentration range for EsophaCap collected specimens ranged from 0.4 to 285ng/uL.

  12 months

• Accuracy of the Oncoguard Esophagus (OGE) test

  Methylated DNA marker (MDM) levels and accuracy (sensitivity and specificity) will be evaluated to determine the accuracy of the OGE test using Cytosponge-collected esophageal samples. Accuracy will be established using upper endoscopy with pathology confirmed histology as the criterion standard for the diagnosis of Barrett's Esophagus (BE). The recently established algorithm for defining the OGE test as positive or negative (from EsophaCap samples collected from another study) will be utilized to adjudicate the Cytosponge samples as positive or negative. Accuracy of the OGE test for the Cytosponge device will be assessed in relation to the estimates and confidence intervals previously observed.

  12 months

Secondary Outcomes (2)

• Tolerability of the Cytosponge device

  7 days

• Trauma to the esophagus from the passage of the Cytosponge device

  7 days

Study Arms (2)

Known or Suspected Barrett's Esophagus (Case Arm)

EXPERIMENTAL

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.

Device: Cytosponge Procedure; Diagnostic Test: Endoscopic Assessment

No Known Barrett's Esophagus (Control Arm)

ACTIVE COMPARATOR

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

Device: Cytosponge Procedure; Diagnostic Test: Endoscopic Assessment

Interventions

Cytosponge Procedure DEVICE

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

Known or Suspected Barrett's Esophagus (Case Arm); No Known Barrett's Esophagus (Control Arm)

Endoscopic Assessment DIAGNOSTIC_TEST

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

Known or Suspected Barrett's Esophagus (Case Arm); No Known Barrett's Esophagus (Control Arm)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (5)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

TERMINATED

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Long Island Jewish Medical Center | Northwell Health

New Hyde Park, New York, 11040, United States

COMPLETED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Barrett Esophagus; Adenocarcinoma Of Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Prasad G. Iyer, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective multi-center case control study

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 10, 2023
• Study Start: October 16, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

US (5)