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

Barrett Esophagus Clinical Trial

Official title:

Office Based Screening Test for Barrett's Esophagus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02451124
• Other study ID #: CASE6214
• Secondary ID: NCI-2015-00246CA
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: January 29, 2017

Study information

• Verified date: November 2019
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: January 29, 2017
• Est. primary completion date: August 11, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus

Intervention

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:
• Questionnaire Administration
Ancillary studies
• Laboratory Biomarker Analysis
Correlative studies

Procedure:
• esophagogastroduodenoscopy
Standard of care, patients digestive tract scoped post balloon brushing

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	Average Methylation of Methylated Beta-1,3-glucuronyltransferase 2 Assays	Average methylation of methylated beta-1,3-glucuronyltransferase 2 assays	Up to 7 months
Primary	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
Primary	Average Methylation of Zinc Finger Protein 793 Assay	Average methylation of zinc finger protein 793 assay	Up to 7 months