Evaluation of MicroRNA Expression in Blood and Cytology for Detecting Barrett's Esophagus and Associated Neoplasia
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Gastroesophageal Reflux Disease , Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | April 2015 |
| End Date: | December 2018 |
| Contact: | Ajay Bansal, MD |
| Email: | ajay.bansal@va.gov |
| Phone: | 57790 |
Evaluation of MicroRNA Expression in Blood and Cytology Specimens as a Novel Method for Detecting Barrett's Esophagus
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.
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.
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.
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.
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.
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