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

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ClinicalTrials.gov Identifier: NCT02451124
Recruitment Status : Completed
First Posted : May 21, 2015
Last Update Posted : February 17, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Barrett Esophagus Device: non-endoscopic inflatable balloon for the esophagus Other: Questionnaire Administration Other: Laboratory Biomarker Analysis Procedure: esophagogastroduodenoscopy Not Applicable

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  (Clinical Trial)
Actual Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Office Based Screening Test for Barrett's Esophagus
Study Start Date : July 2015
Actual Primary Completion Date : August 11, 2016
Actual Study Completion Date : January 29, 2017

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.
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 Name: Balloon

Other: Questionnaire Administration
Ancillary studies

Other: Laboratory Biomarker Analysis
Correlative studies

Procedure: esophagogastroduodenoscopy
Standard of care, patients digestive tract scoped post balloon brushing
Other Name: EGD




Primary Outcome Measures :
  1. Mean tolerance score of variables (anxiety, pain, choking, gagging, and overall tolerance) assessed by the Tolerance Survey [ Time Frame: At completion of study procedure (up to 60 minutes) ]
    Descriptive statistics will be calculated for all tolerance variables. The threshold for tolerability will be a score of =< 3 on 10 point scale for symptoms elicited on the Tolerance Survey.

  2. Performance of the mVIM assay in balloon brushings from subjects with BE [ Time Frame: Up to 7 months ]
    Patient endoscopic and pathologic findings relating to the diagnosis of BE will be compared with mVIM analyses of corresponding esophageal balloon derived samples. The presence of at least 1% of methylated VIM in DNA extracted from the esophageal sampling balloon will be considered a positive assay. The sensitivity and specificity of the balloon mVIM assay for detecting BE will be calculated. Non-endoscopic inflatable balloon for the esophagus mVIM assays will be correlated with endoscopic brushing mVIM assays by calculating a Pearson's correlation coefficient.

  3. Molecular and histological factors that might lead to false negative and false positive VIM assays [ Time Frame: Up to 7 months ]
    Any differences in histo-morphology between BE and esophageal adenocarcinoma that are mVIM negative and mVIM positive on brushings will be explored.

  4. Average methylation of methylated beta-1,3-glucuronyltransferase 2 assays [ Time Frame: Up to 7 months ]
    It will be determined if any of the new biomarkers increase the sensitivity and specificity for BE screening when combined with mVIM. An independent analysis will then be performed where an independent panel of biomarkers for BE screening will be modeled. Using a receiver operating characteristics analysis, biomarkers will be ranked based on the highest area under the curve values. A rank list will also be determined with respect to the overall prevalence of significant methylation in primary BE cases, and the absence of DNA methylation in normal cases.

  5. Performance of the mVIM assay in balloon brushings from subjects without BE [ Time Frame: Up to 7 months ]
    Patient endoscopic and pathologic findings relating to the diagnosis of BE will be compared with mVIM analyses of corresponding esophageal balloon derived samples. The presence of at least 1% of methylated VIM in DNA extracted from the esophageal sampling balloon will be considered a positive assay. The sensitivity and specificity of the balloon mVIM assay for detecting BE will be calculated. Non-endoscopic inflatable balloon for the esophagus mVIM assays will be correlated with endoscopic brushing mVIM assays by calculating a Pearson's correlation coefficient.

  6. Average methylation of zinc finger protein 793 assay [ Time Frame: Up to 7 months ]
    It will be determined if any of the new biomarkers increase the sensitivity and specificity for BE screening when combined with mVIM. An independent analysis will then be performed where an independent panel of biomarkers for BE screening will be modeled. Using a receiver operating characteristics analysis, biomarkers will be ranked based on the highest area under the curve values. A rank list will also be determined with respect to the overall prevalence of significant methylation in primary BE cases, and the absence of DNA methylation in normal cases.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02451124


Locations
United States, Ohio
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Amitabh Chak Case Comprehensive Cancer Center

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02451124     History of Changes
Other Study ID Numbers: CASE6214
NCI-2015-00246 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CASE6214 ( Other Identifier: Case Comprehensive Cancer Center )
P30CA043703 ( U.S. NIH Grant/Contract )
U54CA163060 ( U.S. NIH Grant/Contract )
P50CA150964 ( U.S. NIH Grant/Contract )
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017

Keywords provided by Case Comprehensive Cancer Center:
Barrett
Cancer
Screening

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases