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

Office Based Screening Test for Barrett's Esophagus

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.

Study Overview

• Status: Completed
• Conditions: Barrett Esophagus
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration; Device: non-endoscopic inflatable balloon for the esophagus; Procedure: esophagogastroduodenoscopy

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 Type: Interventional
• Enrollment (Actual): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
    • Cleveland, Ohio, United States, 44106-5065
      • University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Screening: 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.

Other: Laboratory Biomarker Analysis; Correlative studies; Other: Questionnaire Administration; Ancillary studies; Device: non-endoscopic inflatable balloon for the esophagus; Undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus; Other Names: Balloon; Procedure: esophagogastroduodenoscopy; Standard of care, patients digestive tract scoped post balloon brushing; Other Names: EGD

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Amitabh Chak, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): August 11, 2016
• Study Completion (Actual): January 29, 2017

Study Registration Dates

• First Submitted: May 18, 2015
• First Submitted That Met QC Criteria: May 19, 2015
• First Posted (Estimate): May 21, 2015

Study Record Updates

• Last Update Posted (Actual): November 6, 2019
• Last Update Submitted That Met QC Criteria: November 5, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Cancer; Screening; Barrett
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Barrett Esophagus
• Other Study ID Numbers: CASE6214 (Other Identifier: Case Comprehensive Cancer Center); P30CA043703 (U.S. NIH Grant/Contract); P50CA150964 (U.S. NIH Grant/Contract); NCI-2015-00246 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); U54CA163060 (U.S. NIH Grant/Contract)