Evaluation of MicroRNA Expression in Blood and Cytology for Detecting Barrett's Esophagus and Associated Neoplasia
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|ClinicalTrials.gov Identifier: NCT02464930|
Recruitment Status : Unknown
Verified June 2015 by Ajay Bansal, Midwest Biomedical Research Foundation.
Recruitment status was: Recruiting
First Posted : June 8, 2015
Last Update Posted : June 8, 2015
|Condition or disease|
|Barrett's Esophagus Gastroesophageal Reflux Esophageal Adenocarcinoma|
|Study Type :||Observational|
|Estimated Enrollment :||220 participants|
|Observational Model:||Case Control|
|Official Title:||Evaluation of MicroRNA Expression in Blood and Cytology Specimens as a Novel Method for Detecting Barrett's Esophagus|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||December 2018|
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.
• 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
- Sensitivity and specificity of tissue and serum microRNA expression by digital polymerase chain reaction for diagnosis of BE neoplasia [ Time Frame: 1-3 years ]The two main outcomes are the diagnostic accuracy of tissue and serum microRNA for the the diagnosis of Barrett's esophagus compared to endoscopy.
- Differences in the microRNA expression of biliary exosomes between GERD, Barrett's esophagus and Cancer [ Time Frame: 1-3 years ]The microRNA expression will be measured by digital polymerase chain reaction
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02464930
|Contact: Ajay Bansal, MDfirstname.lastname@example.org|
|Contact: Andrew Price, BSemail@example.com|
|United States, Missouri|
|Kansas City Veterans Affairs Medical Center||Recruiting|
|Kansas City, Missouri, United States, 64128|
|Contact: AJAY BANSAL, MD 816-861-4700 ext 57790 Ajay.Bansal@va.gov|
|Contact: Andrew Price, AS 816-861-4700 ext 56428 Andrew.Price2@va.gov|
|Principal Investigator: Ajay Bansal|
|Principal Investigator:||Ajay Bansal, MD||Veterans Affairs Medical Center and the University of Kansas Medical Center|