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

Not Applicable

Completed

• Conditions: Barrett Esophagus
• Interventions: Device: non-endoscopic inflatable balloon for the esophagus; Other: Questionnaire Administration; Other: Laboratory Biomarker Analysis; Procedure: esophagogastroduodenoscopy

• Registration Number: NCT02451124
• Lead Sponsor: Case Comprehensive Cancer Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-05-18
• Study First Submitted QC: 2015-05-19
• Study First Posted: 2015-05-21
• Study Start: 2015-07
• Primary Completion: 2016-08-11
• Study Completion: 2017-01-29
• Results First Submitted: 2019-09-27
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-05
• Last Update Submitted: 2019-11-05
• Results First Posted: 2019-11-06
• Last Update Posted: 2019-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Screening: non-endoscopic inflatable balloon for the esophagus	Questionnaire Administration	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.
Screening: non-endoscopic inflatable balloon for the esophagus	non-endoscopic inflatable balloon for the esophagus	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.
Screening: non-endoscopic inflatable balloon for the esophagus	Laboratory Biomarker Analysis	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.
Screening: non-endoscopic inflatable balloon for the esophagus	esophagogastroduodenoscopy	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey	At completion of study procedure (up to 60 minutes)	Mean tolerance score as assessed by 'tolerance survey' with scores ranging from 0 to 50 with higher scores indicating worse tolerance of interventional balloon device. Subscales include anxiety, pain, choking, gagging, and overall tolerance, with each domain scores ranging from 0 to 10, with higher scores indicating worse tolerance of interventional balloon device.
Sensitivity of the mVIM Assay in Balloon Brushings From Participants With BE	Up to 1 year	Sensitivity of the mVIM assay in balloon brushings from participants with BE as measured by true positives determined by biomarker (mVIM and mCCNA1) analyses of corresponding esophageal balloon derived samples compared to initial diagnosis. The presence of at least 1% of methylated VIM in DNA extracted from the esophageal sampling balloon will be considered a positive assay.
Average Methylation of Zinc Finger Protein 793 Assay	Up to 7 months	Average methylation of zinc finger protein 793 assay
Specificity of the mVIM Assay in Balloon Brushings From Control Participants With no BE Diagnosis	Up to 1 year	Specificity of the mVIM assay in balloon brushings from control subjects with BE as measured by true negatives determined by biomarker (mVIM and mCCNA1) analyses of corresponding esophageal balloon derived samples compared to initial control status. The presence of at least 1% of methylated VIM in DNA extracted from the esophageal sampling balloon will be considered a positive assay.
Average Methylation of Methylated Beta-1,3-glucuronyltransferase 2 Assays	Up to 7 months	Average methylation of methylated beta-1,3-glucuronyltransferase 2 assays
Performance of the mVIM Assay in Balloon Brushings From Subjects Without BE	Up to 7 months	Performance of the mVIM assay in balloon brushings from subjects without BE

Trial Locations

Locations (2)

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States