Clinical trial · Interventional
Non-endoscopic Esophageal Sampling to Detect Barrett's Esophagus and Esophageal Cancer in Veterans
NCT05210049CI-TRIAL-00062698unknownN/AClinicalTrials.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)
This study seeks to incorporate non-endoscopic detection method (Esocheck/Esoguard) in primary care practice and test whether this screening modality increases the positive predictive value of upper endoscopy and increases the detection of Barrett's esophagus and esophageal cancer.
Conditions
Conditions (4)
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 Esophagus | — | UNRESOLVED | — |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| GERD | — | UNRESOLVED | — |
| Obesity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Esocheck/Esoguard | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Patients undergoing routine screening via upper endoscopy (EGD)
- description
- All enrolled patients will complete upper endoscopy for screening for Barrett's esophagus and esophageal adenocarcinoma.
- interventionNames
- Diagnostic Test: Esocheck/Esoguard
Primary outcomes (1)
- measure
- Sensitivity and Specificity of Esocheck/Esoguard in a Veteran population
- timeFrame
- Through study completion, up to 2.5 years
- description
- The accuracy of a test which reports the presence or absence of a condition, in comparison to a 'Gold Standard'
Secondary outcomes (2)
- measure
- Number/percentage of screened patients with diagnosis of Barrett's esophagus and/or esophageal adenocarcinoma
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: Patients who have symptomatic GERD and also meet criteria for upper endoscopic screening for BE will be accrued. Eligible patients will include: 1. Adult Veterans \> 40 and \< 85 years old who have no prior EGD and can provide informed consent 2. No known coagulopathy, no known esophageal varices. 3. No significant dysphagia or odynophagia 4. Documented GERD or use of proton pump inhibitors (PPIs) for \> 5 years 5. Meet ACG Clinical Guideline criteria for BE screening (that require presence of multiple risk factors 21). Eligible subjects to qualify must have will have GERD plus at least two additional risk factors for BE (white race, obesity defined as BMI \> 30, male gender, smoking history, family history). Exclusion Criteria: 1. Patients with known coagulopathy (INR \> 1.5) will be excluded 2. Patients with known esophageal varices will be excluded. 3. Patients with significant dysphagia (unable to swallow solids) or odynophagia will be excluded
References
Publications (5)
- BACKGROUNDGrady WM, Yu M, Markowitz SD, Chak A. Barrett's Esophagus and Esophageal Adenocarcinoma Biomarkers. Cancer Epidemiol Biomarkers Prev. 2020 Dec;29(12):2486-2494. doi: 10.1158/1055-9965.EPI-20-0223. Epub 2020 Oct 22. PMID 33093162
- BACKGROUNDKaz AM, Wong CJ, Luo Y, Virgin JB, Washington MK, Willis JE, Leidner RS, Chak A, Grady WM. DNA methylation profiling in Barrett's esophagus and esophageal adenocarcinoma reveals unique methylation signatures and molecular subclasses. Epigenetics. 2011 Dec;6(12):1403-12. doi: 10.4161/epi.6.12.18199. PMID 22139570
- BACKGROUNDMoinova HR, LaFramboise T, Lutterbaugh JD, Chandar AK, Dumot J, Faulx A, Brock W, De la Cruz Cabrera O, Guda K, Barnholtz-Sloan JS, Iyer PG, Canto MI, Wang JS, Shaheen NJ, Thota PN, Willis JE, Chak A, Markowitz SD. Identifying DNA methylation biomarkers for non-endoscopic detection of Barrett's esophagus. Sci Transl Med. 2018 Jan 17;10(424):eaao5848. doi: 10.1126/scitranslmed.aao5848. PMID 29343623
- BACKGROUNDTan WK, Sharma AN, Chak A, Fitzgerald RC. Progress in Screening for Barrett's Esophagus: Beyond Standard Upper Endoscopy. Gastrointest Endosc Clin N Am. 2021 Jan;31(1):43-58. doi: 10.1016/j.giec.2020.08.004. PMID 33213799
- DERIVEDGreer KB, Blum AE, Faulx AL, Deming EM, Hricik LL, Siddiqui H, Wilson BM, Chak A. Nonendoscopic Screening for Barrett's Esophagus and Esophageal Adenocarcinoma in At-Risk Veterans. Am J Gastroenterol. 2025 Mar 1;120(3):545-553. doi: 10.14309/ajg.0000000000002962. Epub 2024 Jul 11. PMID 38989889