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

Status unconfirmed

Conditions studied: Barrett's Esophagus, Gastroesophageal Reflux, Esophageal Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT02464930

Run by

Midwest Biomedical Research

People needed

220

Starts

2015-04-01

Expected to finish

2018-12-01

Last updated by the study team

2015-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patient age: > 18 years
• Ability to provide written, informed consent

You may not qualify if…

• 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.

Where it is running

• Kansas City Veterans Affairs Medical Center — Kansas City, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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