Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples (SOS4C)

Mayo Clinic

Status: Enrolling

Conditions: Barretts Esophagus With Dysplasia; Barrett's Esophagus Without Dysplasia; Barrett Esophagus; Esophageal Adenocarcinoma

Treatments: Diagnostic Test: Endoscopic Assessment; Device: Cytosponge Procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT06071845

NCI-2023-07131 (Registry Identifier)

22-010506

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES:

I. Measure Deoxyribonucleic acid (DNA) yield from esophageal cytology samples collected with the Cytosponge device.

II. Evaluate the methylated DNA markers (MDM) levels and accuracy of the Oncoguard Esophagus test (OGE test) for the detection of methylated DNA markers in Cytosponge collected esophageal cytology samples.

SECONDARY OBJECTIVES:

I. Assess the tolerability of the Cytosponge device using a tolerability questionnaire II. Evaluate presence of any trauma to the esophagus from the passage of the Cytosponge device using the endoscopic injury score.

OUTLINE: Patients are assigned to 1 of 2 arms.

ARM I: Patients with known or suspected Barrett's Esophagus undergo a biopsy and sample collection with the cytosponge followed by standard of care endoscopy and complete surveys while on study.

ARM II: Patients without known or suspected Barrett's Esophagus undergo a biopsy and sample collection with the cytosponge followed by standard of care endoscopy and complete surveys while on study.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Known or Suspected Barrett's Esophagus (Case Arm)

Experimental group

Description:

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.

Treatment:

Device: Cytosponge Procedure

Diagnostic Test: Endoscopic Assessment

No Known Barrett's Esophagus (Control Arm)

Active Comparator group

Description:

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

Treatment:

Device: Cytosponge Procedure

Diagnostic Test: Endoscopic Assessment