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

Sponsor

Mayo Clinic (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02560623

Collaborator

Exact Sciences Corporation (Industry)

1,000

Enrollment

Locations

Arms

Duration (Months)

142.9

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Barrett's Esophagus	Device: Sponge capsule	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Minimally-Invasive Detection of Barrett's Esophagus and Barrett's Esophagus Related Dysplasia/Carcinoma by a Sponge on String Device

Study Start Date :

Oct 1, 2015

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cases - Barrett's Esophagus Subjects will have sponge capsule procedure, blood draw, and clinically indicated endoscopy with endoscopic brushings of the esophagus.	Device: Sponge capsule Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge. Other Names: EsophaCap
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.	Device: Sponge capsule Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge. Other Names: EsophaCap

Arm

Intervention/Treatment

Active Comparator: Cases - Barrett's Esophagus

Subjects will have sponge capsule procedure, blood draw, and clinically indicated endoscopy with endoscopic brushings of the esophagus.

Device: Sponge capsule

Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge.

Other Names:

EsophaCap

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.

Device: Sponge capsule

Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge.

Other Names:

EsophaCap

Outcome Measures

Primary Outcome Measures

Sensitivity and specificity of Barrett's Esophagus Diagnosis [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 Outcome Measures

Sensitivity and specificity of Barrett's dysplasia detection [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion criteria:

Subjects with known Barrett's Esophagus (BE).

Patient between the ages 18 - 90.
Patients with a BE segment ≥ 1cm in maximal extent endoscopically.
Histology showing evidence of intestinal metaplasia with or without presence of dysplasia.
Undergoing clinically indicated endoscopy.

Subjects without known evidence of BE

Undergoing clinically indicated diagnostic endoscopy.

Exclusion criteria:

Subjects with known BE.

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.
Patients with history of esophageal resection for esophageal carcinoma.

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 eosinophilic esophagitis, achalasia or uninvestigated dysphagia.
Patients on oral anticoagulation including Coumadin, Warfarin.
Patients on antiplatelet agents including Clopidogrel, unless discontinued for 3 days prior to the sponge procedure.
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.
Patients with history of known varices or cirrhosis.
Patients with history of 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Arizona	Scottsdale	Arizona	United States	85259
2	Mayo Clinic Jacksonville	Jacksonville	Florida	United States	32224
3	Mayo Clinic Health Systems - Austin	Austin	Minnesota	United States	55912
4	Mayo Clinic Health System - Mankato	Mankato	Minnesota	United States	56001
5	Mayo Clinic Rochester	Rochester	Minnesota	United States	55905
6	Northwell Health	Manhasset	New York	United States	11030
7	Baylor University Medical Center	Dallas	Texas	United States	75246