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

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ClinicalTrials.gov Identifier: NCT02464930
Recruitment Status : Recruiting
First Posted : June 8, 2015
Last Update Posted : June 8, 2015
Sponsor:
Collaborators:
Kansas City Veteran Affairs Medical Center
University of Kansas
Information provided by (Responsible Party):
Ajay Bansal, Midwest Biomedical Research Foundation

Study Description
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Brief Summary:
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.

Condition or disease
Barrett's Esophagus Gastroesophageal Reflux Esophageal Adenocarcinoma

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 Design
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Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation of MicroRNA Expression in Blood and Cytology Specimens as a Novel Method for Detecting Barrett's Esophagus
Study Start Date : April 2015
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
blood, bile and tissue in a repository

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02464930


Contacts
Contact: Ajay Bansal, MD 57790 ajay.bansal@va.gov
Contact: Andrew Price, BS 56428 andrew.price@va.gov

Locations
United States, Missouri
Kansas City Veterans Affairs Medical Center Recruiting
Kansas City, Missouri, United States, 64128
Contact: AJAY BANSAL, MD    816-861-4700 ext 57790    Ajay.Bansal@va.gov   
Contact: Andrew Price, AS    816-861-4700 ext 56428    Andrew.Price2@va.gov   
Principal Investigator: Ajay Bansal         
Sponsors and Collaborators
Midwest Biomedical Research Foundation
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
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Responsible Party: Ajay Bansal, Associate Professor of Medicine and Staff Gastroenterologist, Midwest Biomedical Research Foundation
ClinicalTrials.gov Identifier: NCT02464930     History of Changes
Other Study ID Numbers: AB0009
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015

Keywords provided by Ajay Bansal, Midwest Biomedical Research Foundation:
Blood
Cytology
Esophagus
microRNA

Additional relevant MeSH terms:
Adenocarcinoma
Gastroesophageal Reflux
Barrett Esophagus
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Esophageal Motility Disorders
 Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Digestive System Abnormalities
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms