Clinical trial NCT02464930: Evaluation of MicroRNA Expression in Blood and Cytology for Detecting Barrett's Esophagus and Associated Neoplasia
Official title: Evaluation of MicroRNA Expression in Blood and Cytology Specimens as a Novel Method for Detecting Barrett's Esophagus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Barrett's Esophagus
Gastroesophageal Reflux
Esophageal Adenocarcinoma
Keywords: Blood
Cytology
Esophagus
microRNA
Lead sponsor: Midwest Veterans' Biomedical Research Foundation
Sponsor class: OTHER
Collaborators: name: Kansas City Veteran Affairs Medical Center
name: University of Kansas
First posted: 2015-06-08
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Sensitivity and specificity of tissue and serum microRNA expression by digital polymerase chain reaction for diagnosis of BE neoplasia
timeFrame: 1-3 years
Secondary outcomes:
measure: Differences in the microRNA expression of biliary exosomes between GERD, Barrett's esophagus and Cancer
timeFrame: 1-3 years
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Kansas City Veterans Affairs Medical Center
state: Missouri
Study officials:
affiliation: Veterans Affairs Medical Center and the University of Kansas Medical Center
name: Ajay Bansal, MD
role: PRINCIPAL_INVESTIGATOR
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