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

Gastroesophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02464930
• Other study ID #: AB0009
• Status: Recruiting
• Phase: N/A
• First received: June 2, 2015
• Last updated: June 4, 2015
• Start date: April 2015
• Est. completion date: December 2018

Study information

• Verified date: June 2015
• Source: Midwest Biomedical Research Foundation
• Contact: Ajay Bansal, MD
• Phone: 57790
• Email: ajay.bansal[@]va.gov
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adenocarcinoma
• Barrett Esophagus
• Barrett's Esophagus
• Esophageal Adenocarcinoma
• Esophageal Neoplasms
• Gastroesophageal Reflux

Locations

Country	Name	City	State
United States	Kansas City Veterans Affairs Medical Center	Kansas City	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Midwest Biomedical Research Foundation	Kansas City Veteran Affairs Medical Center, University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (43)

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* Note: There are 43 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of tissue and serum microRNA expression by digital polymerase chain reaction for diagnosis of BE neoplasia	The two main outcomes are the diagnostic accuracy of tissue and serum microRNA for the the diagnosis of Barrett's esophagus compared to endoscopy.	1-3 years	No
Secondary	Differences in the microRNA expression of biliary exosomes between GERD, Barrett's esophagus and Cancer	The microRNA expression will be measured by digital polymerase chain reaction	1-3 years	No