NCT02464930

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

Evaluation of MicroRNA Expression in Blood and Cytology Specimens as a Novel Method for Detecting Barrett's Esophagus

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 220 (estimated)
• Sponsor: Midwest Biomedical Research Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Barrett's Esophagus
• Gastroesophageal Reflux
• Esophageal Adenocarcinoma

Timeline

• Start date: 2015-04-01
• Primary completion: 2018-04-01
• Completion: 2018-12-01
• First posted: 2015-06-08
• Last updated: 2015-06-08

Locations

1 site across 1 country: United States