Evaluation of MicroRNA Expression in Blood and Cytology for Detecting Barrett's Esophagus and Associated Neoplasia
NCT ID: NCT02464930
Last Updated: 2015-06-08
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
220 participants
Study Classification
OBSERVATIONAL
Study Start Date
2015-04-30
Study Completion Date
2018-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Barrett's Esophagus
Gastroesophageal Reflux
Esophageal Adenocarcinoma
Study Design
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Observational Model Type
CASE_CONTROL
Study Time Perspective
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patient age: \> 18 years
* Ability to provide written, informed consent
* 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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Kansas City Veteran Affairs Medical Center
FED
Sponsor Role
collaborator
University of Kansas
OTHER
Sponsor Role
collaborator
Midwest Biomedical Research Foundation
OTHER
Sponsor Role
lead
Responsible Party
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Ajay Bansal
Associate Professor of Medicine and Staff Gastroenterologist
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Ajay Bansal, MD
Role: PRINCIPAL_INVESTIGATOR
Veterans Affairs Medical Center and the University of Kansas Medical Center
Locations
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Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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AB0009
Identifier Type: -
Identifier Source: org_study_id
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