Barrett's Esophagus, Esophageal Adenocarcinoma, Gastroesophageal Reflux
Conditions
Keywords
Blood, Cytology, Esophagus, microRNA
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.
Interventions
None listed
Sponsors
Kansas City Veteran Affairs Medical Center
University of Kansas
Midwest Biomedical Research Foundation
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactAjay Bansal, MD
Backup ContactAndrew Price, BS
Outcome results
None listed