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| Name | Class |
|---|---|
| Kansas City Veteran Affairs Medical Center | FED |
| University of Kansas | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No-GERD Controls | 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.
| ||
| GERD Controls |
| ||
| BE Cases | • 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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Patients will be recruited at the Kansas City VA Hospital and the Mobile Medical unit of the Kansas City VA. The Mobile Medical Unit (MMU) travels to multiple counties to provide health care to the veterans at their doorstep. This is a program that has been in place for several years and continues to grow. Currently, the MMU provides services such as basic health evaluations and phlebotomy to ~600 veterans per week.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ajay Bansal, MD | Contact | 57790 | ajay.bansal@va.gov | |
| Andrew Price, BS | Contact | 56428 | andrew.price@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Ajay Bansal, MD | Veterans Affairs Medical Center and the University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kansas City Veterans Affairs Medical Center | Recruiting | Kansas City | Missouri | 64128 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23853213 | Background | El-Serag HB, Sweet S, Winchester CC, Dent J. Update on the epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut. 2014 Jun;63(6):871-80. doi: 10.1136/gutjnl-2012-304269. Epub 2013 Jul 13. | |
| 25162890 | Background | Spechler SJ, Souza RF. Barrett's esophagus. N Engl J Med. 2014 Aug 28;371(9):836-45. doi: 10.1056/NEJMra1314704. No abstract available. |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| D005764 | Gastroesophageal Reflux |
| C562730 | Adenocarcinoma Of Esophagus |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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blood, bile and tissue in a repository
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| D004066 |
| Digestive System Diseases |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |