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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Office Based Screening Test for Barrett's Esophagus

Conditions
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Barrett Esophagus

Intervention / Treatment
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* Device: non-endoscopic inflatable balloon for the esophagus
* Other: Questionnaire Administration
* Other: Laboratory Biomarker Analysis
* Procedure: esophagogastroduodenoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Screening: non-endoscopic inflatable balloon for the esophagus<br>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. | Device: non-endoscopic inflatable balloon for the esophagus<br>* Undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus<br>* Other names: Balloon;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Procedure: esophagogastroduodenoscopy<br>* Standard of care, patients digestive tract scoped post balloon brushing<br>* Other names: EGD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey | 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. | At completion of study procedure (up to 60 minutes) | 
| Sensitivity of the mVIM Assay in Balloon Brushings From Participants With BE | 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. | Up to 1 year | 
| Specificity of the mVIM Assay in Balloon Brushings From Control Participants With no BE Diagnosis | 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. | Up to 1 year | 
| Average Methylation of Methylated Beta-1,3-glucuronyltransferase 2 Assays | Average methylation of methylated beta-1,3-glucuronyltransferase 2 assays | Up to 7 months | 
| Performance of the mVIM Assay in Balloon Brushings From Subjects Without BE | Performance of the mVIM assay in balloon brushings from subjects without BE | Up to 7 months | 
| Average Methylation of Zinc Finger Protein 793 Assay | Average methylation of zinc finger protein 793 assay | Up to 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Barrett, Cancer, Screening