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

Midwest Biomedical Research Foundation

Status: Unknown

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

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02464930

AB0009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

220 participants in 3 patient groups

No-GERD Controls

Description:

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

Description:

* 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

Description:

• 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