Evaluation of MicroRNA Expression in Blood and Cytology for Detecting Barrett's Esophagus and Associated Neoplasia

June 4, 2015 updated by: Ajay Bansal, Midwest Biomedical Research Foundation

Evaluation of MicroRNA Expression in Blood and Cytology Specimens as a Novel Method for Detecting Barrett's Esophagus

The primary purpose of this study is to test new methods to diagnose BE in time before it turns into advanced cancer. Once BE is diagnosed, the current standard of care is to monitor the disease so that complication such as cancer can be diagnosed early. The two new methods the investigators are evaluating are: a) blood test and b) brush test of the food pipe. The investigators will collect blood, bile and cells from the food pipe and stomach and measure for a biomarker called microRNA (miRNA). In the future, measurements of microRNA biomarkers could help the doctors figure out which patients are at increased risk for cancer of the esophagus.

Study Overview

Status

Unknown

Conditions

Detailed Description

The investigators will collect serum, bile and esophageal cells (using cytology devices) from consenting subjects. The investigators have previously identified BE specific miRNA that will be tested on the cytology specimens. These are miRNAs -192-5p, -215-5p and -194-5p. The investigators have also identified serum microRNAs in whole serum and exosomes by sequencing to study further. The investigators will also evaluate miRNA expression within biliary exosomes for the first time in patients with reflux related diseases.

Study Type

Observational

Enrollment (Anticipated)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Recruiting
        • Kansas City Veterans Affairs Medical Center
        • Principal Investigator:
          • Ajay Bansal
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients will be recruited at the Kansas City VA Hospital and the Mobile Medical unit of the Kansas City VA. The Mobile Medical Unit (MMU) travels to multiple counties to provide health care to the veterans at their doorstep. This is a program that has been in place for several years and continues to grow. Currently, the MMU provides services such as basic health evaluations and phlebotomy to ~600 veterans per week.

Description

Inclusion Criteria:

  • Patient age: > 18 years
  • Ability to provide written, informed consent

Exclusion Criteria:

  • Pregnancy or planning a pregnancy
  • History of nasal, esophageal & gastric surgery
  • History of recurrent epistaxis or nasal trauma
  • Subjects with a history of unresolved drug or alcohol dependency
  • Inability to obtain biopsies due to a coagulopathy, varices, thrombocytopenia, etc.
  • Subjects with inadequate cytology specimens will not undergo repeat test and will be excluded from the study
  • Inability to provide written informed consent
  • Inability to discontinue drugs such as Plavix
  • Advanced chronic liver disease
  • Severe uncontrolled coagulopathy
  • Active cancer in any organ over the past 3 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
No-GERD Controls

NERD controls will be enrolled from subjects presenting to the endoscopy unit who are being evaluated for reasons other than GERD or BE surveillance. These are patients who are referred to the endoscopy unit for: evaluation of anemia, dysphagia, occult blood positivity, gastrointestinal blood loss etc.

  • No history of GERD
  • Response "no" to presence of symptoms on a standardized GERD questionnaire
  • No prescriptions for acid suppressive medication over the past 2 years as documented in electronic pharmacy records.
  • Normal endoscopy that does not find Barrett's esophagus, hiatus hernia or erosive esophagitis.
GERD Controls
  • Respond "yes" to the presence of symptoms on a standardized GERD questionnaire
  • Prescriptions for acid suppressive medication as documented in electronic pharmacy records.
BE Cases
• Patients who present for evaluation of reflux symptoms and are found to have at least 1 cm of columnar lined esophagus on endoscopy with intestinal metaplasia on biopsies. This will include patients with esophageal adenocarcinoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of tissue and serum microRNA expression by digital polymerase chain reaction for diagnosis of BE neoplasia
Time Frame: 1-3 years
The two main outcomes are the diagnostic accuracy of tissue and serum microRNA for the the diagnosis of Barrett's esophagus compared to endoscopy.
1-3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in the microRNA expression of biliary exosomes between GERD, Barrett's esophagus and Cancer
Time Frame: 1-3 years
The microRNA expression will be measured by digital polymerase chain reaction
1-3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Midwest Biomedical Research Foundation

Collaborators

Kansas City Veteran Affairs Medical Center
University of Kansas

Investigators

  • Principal Investigator: Ajay Bansal, MD, Veterans Affairs Medical Center and the University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

April 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

June 2, 2015

First Submitted That Met QC Criteria

June 4, 2015

First Posted (Estimate)

June 8, 2015

Study Record Updates

Last Update Posted (Estimate)

June 8, 2015

Last Update Submitted That Met QC Criteria

June 4, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB0009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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