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.
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
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
156
Undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus
Ancillary studies
Correlative studies
Standard of care, patients digestive tract scoped post balloon brushing
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
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 1 year
Average Methylation of Methylated Beta-1,3-glucuronyltransferase 2 Assays
Average methylation of methylated beta-1,3-glucuronyltransferase 2 assays
Time frame: 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
Time frame: Up to 7 months
Average Methylation of Zinc Finger Protein 793 Assay
Average methylation of zinc finger protein 793 assay
Time frame: Up to 7 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.