Clinical trial · Observational
Evaluation of MicroRNA Expression in Blood and Cytology for Detecting Barrett's Esophagus and Associated Neoplasia
Evaluation of MicroRNA Expression in Blood and Cytology Specimens as a Novel Method for Detecting Barrett's Esophagus
NCT02464930CI-TRIAL-00018203unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett's Esophagus | — | UNRESOLVED | — |
| Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Gastroesophageal Reflux | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- No-GERD Controls
- description
- 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. * No history of GERD * Response "no" to presence of symptoms on a standardized GERD questionnaire * No prescriptions for acid suppressive medication over the past 2 years as documented in electronic pharmacy records. * Normal endoscopy that does not find Barrett's esophagus, hiatus hernia or erosive esophagitis.
- label
- GERD Controls
- description
- * Respond "yes" to the presence of symptoms on a standardized GERD questionnaire * Prescriptions for acid suppressive medication as documented in electronic pharmacy records.
- label
- BE Cases
- description
- • 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
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (43)
- BACKGROUNDEl-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. PMID 23853213
- BACKGROUNDSpechler SJ, Souza RF. Barrett's esophagus. N Engl J Med. 2014 Aug 28;371(9):836-45. doi: 10.1056/NEJMra1314704. No abstract available. PMID 25162890
- BACKGROUNDRajendra S, Sharma P. Barrett's Esophagus. Curr Treat Options Gastroenterol. 2014 Jun;12(2):169-82. doi: 10.1007/s11938-014-0012-0. PMID 24634008
- BACKGROUNDWeaver JMJ, Ross-Innes CS, Shannon N, Lynch AG, Forshew T, Barbera M, Murtaza M, Ong CJ, Lao-Sirieix P, Dunning MJ, Smith L, Smith ML, Anderson CL, Carvalho B, O'Donovan M, Underwood TJ, May AP, Grehan N, Hardwick R, Davies J, Oloumi A, Aparicio S, Caldas C, Eldridge MD, Edwards PAW, Rosenfeld N, Tavare S, Fitzgerald RC; OCCAMS consortium. Ordering of mutations in preinvasive disease stages of esophageal carcinogenesis. Nat Genet. 2014 Aug;46(8):837-843. doi: 10.1038/ng.3013. Epub 2014 Jun 22. PMID 24952744
- BACKGROUNDHamilton SR, Smith RR, Cameron JL. Prevalence and characteristics of Barrett esophagus in patients with adenocarcinoma of the esophagus or esophagogastric junction. Hum Pathol. 1988 Aug;19(8):942-8. doi: 10.1016/s0046-8177(88)80010-8. PMID 3402983
- BACKGROUNDdi Pietro M, Alzoubaidi D, Fitzgerald RC. Barrett's esophagus and cancer risk: how research advances can impact clinical practice. Gut Liver. 2014 Jul;8(4):356-70. doi: 10.5009/gnl.2014.8.4.356. Epub 2014 Jul 1. PMID 25071900
- BACKGROUNDAmerican Gastroenterological Association; Spechler SJ, Sharma P, Souza RF, Inadomi JM, Shaheen NJ. American Gastroenterological Association medical position statement on the management of Barrett's esophagus. Gastroenterology. 2011 Mar;140(3):1084-91. doi: 10.1053/j.gastro.2011.01.030. No abstract available.