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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
Results First Posted : November 6, 2019
Last Update Posted : November 6, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE May 18, 2015
First Posted Date  ICMJE May 21, 2015
Results First Submitted Date  ICMJE September 27, 2019
Results First Posted Date  ICMJE November 6, 2019
Last Update Posted Date November 6, 2019
Study Start Date  ICMJE July 2015
Actual Primary Completion Date August 11, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2019)
  • Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey [ Time Frame: At completion of study procedure (up to 60 minutes) ]
    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.
  • Sensitivity of the mVIM Assay in Balloon Brushings From Participants With BE [ Time Frame: Up to 1 year ]
    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.
  • Specificity of the mVIM Assay in Balloon Brushings From Control Participants With no BE Diagnosis [ Time Frame: Up to 1 year ]
    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.
  • Average Methylation of Methylated Beta-1,3-glucuronyltransferase 2 Assays [ Time Frame: Up to 7 months ]
    Average methylation of methylated beta-1,3-glucuronyltransferase 2 assays
  • Performance of the mVIM Assay in Balloon Brushings From Subjects Without BE [ Time Frame: Up to 7 months ]
    Performance of the mVIM assay in balloon brushings from subjects without BE
  • Average Methylation of Zinc Finger Protein 793 Assay [ Time Frame: Up to 7 months ]
    Average methylation of zinc finger protein 793 assay
Original Primary Outcome Measures  ICMJE
 (submitted: May 19, 2015)
  • Tolerance 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.
  • Performance of the mVIM assay in balloon brushings from subjects with and 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.
  • 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.
  • Additional methylation DNA biomarker (including methylated beta-1,3-glucuronyltransferase 2 and zinc finger protein 793) analysis [ 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Non-endoscopic Brushing of the Esophagus Using a Non-endoscopic Inflatable Balloon of the Esophagus in Screening for Barrett Esophagus
Official Title  ICMJE Office Based Screening Test for Barrett's Esophagus
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Barrett Esophagus
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Device: non-endoscopic inflatable balloon for the esophagus
  • Other: Questionnaire Administration
  • Other: Laboratory Biomarker Analysis
  • Procedure: esophagogastroduodenoscopy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 5, 2019)
156
Original Estimated Enrollment  ICMJE
 (submitted: May 19, 2015)
120
Actual Study Completion Date  ICMJE January 29, 2017
Actual Primary Completion Date August 11, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02451124
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Case Comprehensive Cancer Center
Study Sponsor  ICMJE Case Comprehensive Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Amitabh Chak Case Comprehensive Cancer Center
PRS Account Case Comprehensive Cancer Center
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP