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

Official title

Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples for the Non-endoscopic Detection of Barrett's Esophagus With and Without Dysplasia

Overview

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.

Detailed 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.

Interventions

• Device Cytosponge Procedure
  Investigators will follow the Cytosponge Cell Collection Kit Instructions for Use to administer and retrieve the Cytosponge device.
• Diagnostic test Endoscopic Assessment
  Participants will undergo a diagnostic clinically indicated sedated endoscopy with standard endoscopic equipment.

Primary outcome measures

• 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]

Secondary outcome measures (2)

• Tolerability of the Cytosponge device [Time frame: 7 days]
• Trauma to the esophagus from the passage of the Cytosponge device [Time frame: 7 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Screening

Study locations

United States · 5 centers

• Mayo Clinic — Scottsdale
• Mayo Clinic in Florida — Jacksonville
• Northwestern University — Chicago
• Mayo Clinic in Rochester — Rochester
• Long Island Jewish Medical Center | Northwell Health — New Hyde Park

Identifiers

NCT: NCT06071845 · 22-010506

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗