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

• Conditions: Gastroesophageal Reflux; Esophageal Adenocarcinoma; Barrett's Esophagus

• Registration Number: NCT02464930
• Lead Sponsor: Midwest Biomedical Research Foundation

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.

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 Timeline

• Study Start: 2015-04
• Status Verified: 2015-06
• Study First Submitted: 2015-06-02
• Study First Submitted QC: 2015-06-04
• Last Update Submitted: 2015-06-04
• Study First Posted: 2015-06-08
• Last Update Posted: 2015-06-08
• Primary Completion: 2018-04
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of tissue and serum microRNA expression by digital polymerase chain reaction for diagnosis of BE neoplasia	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

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

Trial Locations

Locations (1)

Kansas City Veterans Affairs Medical Center; 🇺🇸 Kansas City, Missouri, United States