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Completed

NCT Number: NCT02451124

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

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.

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Key information

Conditions

Barrett Esophagus Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

non-endoscopic inflatable balloon for the esophagus

Device

Undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus

Other names: Balloon

Questionnaire Administration

Other

Ancillary studies

laboratory biomarker analysis

Other

Correlative studies

Esophagogastroduodenoscopy

Procedure

Standard of care, patients digestive tract scoped post balloon brushing

Other names: EGD

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. Average Methylation of Zinc Finger Protein 793 Assay

    Time frame: Up to 7 months

    Average methylation of zinc finger protein 793 assay

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Office Based Screening Test for Barrett's Esophagus

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
May 21, 2015
Registry last updated
Nov 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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