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

Sponsor

Midwest Biomedical Research Foundation (Other)

Overall Status

Unknown status

CT.gov ID

NCT02464930

Collaborator

Kansas City Veteran Affairs Medical Center (U.S. Fed), University of Kansas (Other)

220

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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

Study Type:

Observational

Anticipated 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 :

Apr 1, 2015

Anticipated Primary Completion Date :

Apr 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.