Clinical trial NCT02451124: Non-endoscopic Brushing of the Esophagus Using a Non-endoscopic Inflatable Balloon of the Esophagus in Screening for Barrett Esophagus
Official title: Office Based Screening Test for Barrett's Esophagus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Barrett Esophagus
Keywords: Barrett
Cancer
Screening
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-05-21
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey
timeFrame: At completion of study procedure (up to 60 minutes)
measure: Sensitivity of the mVIM Assay in Balloon Brushings From Participants With BE
timeFrame: Up to 1 year
measure: Specificity of the mVIM Assay in Balloon Brushings From Control Participants With no BE Diagnosis
timeFrame: Up to 1 year
measure: Average Methylation of Methylated Beta-1,3-glucuronyltransferase 2 Assays
timeFrame: Up to 7 months
measure: Performance of the mVIM Assay in Balloon Brushings From Subjects Without BE
timeFrame: Up to 7 months
measure: Average Methylation of Zinc Finger Protein 793 Assay
timeFrame: Up to 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Amitabh Chak
role: PRINCIPAL_INVESTIGATOR
References: