Non-endoscopic Brushing of the Esophagus Using a Non-endoscopic Inflatable Balloon of the Esophagus in Screening for Barrett Esophagus

Case Comprehensive Cancer Center (Case CCC)

Status: Completed

Conditions: Barrett Esophagus

Treatments: Other: Questionnaire Administration; Other: Laboratory Biomarker Analysis; Device: non-endoscopic inflatable balloon for the esophagus; Procedure: esophagogastroduodenoscopy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02451124

U54CA163060 (U.S. NIH Grant/Contract)

CASE6214 (Other Identifier)

P50CA150964 (U.S. NIH Grant/Contract)

P30CA043703 (U.S. NIH Grant/Contract)

NCI-2015-00246 (Registry Identifier)

Details and patient eligibility

About

This pilot clinical trial studies non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus in screening for Barrett esophagus, a condition where the lining of the esophagus has changed or been replaced with abnormal cells that may lead to cancer. The non-endoscopic inflatable balloon for the esophagus is a capsule balloon that brushes against the walls of the esophagus to collect esophageal samples. Non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus may help doctors find Barrett esophagus sooner, when it may be easier to treat.

Full description

PRIMARY OBJECTIVES:

I. To determine acceptability of non-endoscopic balloon brushing of esophagus.

II. To demonstrate successful performance of the methylation of vimentin (mVIM) assay in balloon brushings from subjects with and without Barrett's Esophagus (BE).

III. To examine molecular and histological factors that might lead to false negative and false positive mVIM assays in BE screening.

IV. To assay additional methylated deoxyribonucleic acid (DNA) biomarkers that might improve the sensitivity and specificity of mVIM in balloon brushings.

OUTLINE:

Patients undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus over 30-60 minutes followed by a standard esophagogastroduodenoscopy (EGD).

After completion of study, patients with serious adverse events are followed up until resolution, stabilization, or until it has been determined that the study treatment or participation is not the cause.

Enrollment: 156 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients are undergoing clinically indicated esophagogastroduodenoscopy (EGD)
• Patients can provide informed consent
• Patients have no known coagulopathy and no known history of esophageal varices

Exclusion criteria

• Patients are not undergoing clinically indicated EGD
• Patients have known coagulopathies or history of esophageal varices
• Patients do not have the ability to give informed consent

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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156 participants in 1 patient group

Screening: non-endoscopic inflatable balloon for the esophagus

Experimental group

Description:

Patients undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus over 30-60 minutes followed by a standard esophagogastroduodenoscopy. Questionnaire administration will provide self-reported data on patient experiences. laboratory biomarker analysis of biopsy will confirm diagnosis.

Treatment:

Procedure: esophagogastroduodenoscopy

Other: Laboratory Biomarker Analysis

Device: non-endoscopic inflatable balloon for the esophagus

Other: Questionnaire Administration