Minimally-Invasive Detection of Barrett’s Esophagus and Barrett’s Esophagus Related Dysplasia/Carcinoma

Overview

This study will evaluate if the capsule sponge device can detect the presence of Barrett's Esophagus

Full Title of Study: “Minimally-Invasive Detection of Barrett’s Esophagus and Barrett’s Esophagus Related Dysplasia/Carcinoma by a Sponge on String Device”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Screening
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2020

Detailed Description

Assess the sensitivity and specificity of a panel of DNA methylation markers in the non-endoscopic detection of Barrett's Esophagus as well as dysplasia/carcinoma using a capsule sponge device.

Interventions

  • Device: Sponge capsule
    • Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge.

Arms, Groups and Cohorts

  • Active Comparator: Cases – Barrett’s Esophagus
    • Subjects will have sponge capsule procedure, blood draw, and clinically indicated endoscopy with endoscopic brushings of the esophagus.
  • Active Comparator: Controls – No Barrett’s Esophagus
    • Subjects will have sponge capsule procedure, blood draw, and clinically indicated endoscopy with endoscopic biopsies of the esophagus.

Clinical Trial Outcome Measures

Primary Measures

  • Sensitivity and specificity of Barrett’s Esophagus Diagnosis
    • Time Frame: 2 years. Interim analysis after 50% recruitment is complete at approximately 9 months.
    • The sensitivity and specificity of methylated DNA markers detected by the capsule sponge, in making a diagnosis of BE will be assessed using endoscopic examination as a gold standard.

Secondary Measures

  • Sensitivity and specificity of Barrett’s dysplasia detection
    • Time Frame: 2 years. Interim analysis after 50% recruitment is complete at approximately 9 months.
    • The sensitivity and specificity of methylated DNA markers detected by the capsule sponge, in making a diagnosis of BE related dysplasia will be assessed using endoscopic surveillance biopsy histology as a gold standard.

Participating in This Clinical Trial

Inclusion Criteria

Subjects with known Barrett's Esophagus (BE).

1. Patient between the ages 18 – 90.

2. Patients with a BE segment ≥ 1cm in maximal extent endoscopically.

3. Histology showing evidence of intestinal metaplasia with or without presence of dysplasia.

4. Undergoing clinically indicated endoscopy.

Subjects without known evidence of BE

1. Undergoing clinically indicated diagnostic endoscopy.

Exclusion Criteria

Subjects with known BE.

1. Patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with history of endoscopic mucosal resection alone will not be excluded.

2. Patients with history of esophageal or gastric resection.

Subjects with or without known evidence of BE (on history or review of medical records).

1. Pregnant or lactating females.

2. Patients who are unable to consent.

3. Patients with current history of eosinophilic esophagitis, achalasia or uninvestigated dysphagia.

4. Patients on oral anticoagulation including Coumadin, Warfarin.

5. Patients on antiplatelet agents including Clopidogrel, unless discontinued for 3 days prior to the sponge procedure.

6. Patients on oral thrombin inhibitors including Dabigatran and oral factor X a inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for 3 days prior to the sponge procedure.

7. Patients with history of known varices or cirrhosis.

8. Patients with history of esophageal or gastric resection.

9. Patients with congenital or acquired bleeding diatheses.

10. Patients with a history of esophageal squamous dysplasia.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Collaborator
    • Exact Sciences Corporation
  • Provider of Information About this Clinical Study
    • Principal Investigator: Prasad G. Iyer, MD – Mayo Clinic
  • Overall Official(s)
    • Prasad G Iyer, MD, Principal Investigator, Mayo Clinic
  • Overall Contact(s)
    • Michele L Johnson, CCRP, 507-255-8692, johnson.michele@mayo.edu

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