Non-endoscopic Esophageal Sampling to Detect Barrett's Esophagus and Esophageal Cancer in Veterans
1 other identifier
interventional
125
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2021
CompletedFirst Posted
Study publicly available on registry
January 27, 2022
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedDecember 15, 2022
December 1, 2022
2.5 years
December 16, 2021
December 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sensitivity and Specificity of Esocheck/Esoguard in a Veteran population
The accuracy of a test which reports the presence or absence of a condition, in comparison to a 'Gold Standard'
Through study completion, up to 2.5 years
Secondary Outcomes (2)
Number/percentage of screened patients with diagnosis of Barrett's esophagus and/or esophageal adenocarcinoma
Through study completion, up to 2.5 years
Cost of two screening strategies
Through study completion, up to 2.5 years
Study Arms (1)
Patients undergoing routine screening via upper endoscopy (EGD)
OTHERAll enrolled patients will complete upper endoscopy for screening for Barrett's esophagus and esophageal adenocarcinoma.
Interventions
All enrolled patients will complete the Esocheck screening test. EsoCheck is a cell collection device that is designed to collect cells of a targeted region of the esophagus. The collected cell material is examined with a two marker panel combining methylated CCNA1 and VIM. These methylated markers have 95% sensitivity and 91% specificity for detecting BE and EAC with an AUC=0.95 in studies performed among white men. Diagnostic yield of this test among Veterans is unknown.
Eligibility Criteria
You may qualify if:
- Patients who have symptomatic GERD and also meet criteria for upper endoscopic screening for BE will be accrued. Eligible patients will include:
- Adult Veterans \> 40 and \< 85 years old who have no prior EGD and can provide informed consent
- No known coagulopathy, no known esophageal varices.
- No significant dysphagia or odynophagia
- Documented GERD or use of proton pump inhibitors (PPIs) for \> 5 years
- 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).
You may not qualify if:
- Patients with known coagulopathy (INR \> 1.5) will be excluded
- Patients with known esophageal varices will be excluded.
- Patients with significant dysphagia (unable to swallow solids) or odynophagia will be excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio, 44016, United States
Related Publications (5)
Grady 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: 33093162BACKGROUNDKaz 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: 22139570BACKGROUNDMoinova 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: 29343623BACKGROUNDTan 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: 33213799BACKGROUNDGreer 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: 38989889DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katarina B Greer, MD/MS
Louis Stokes Cleveland VA Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2021
First Posted
January 27, 2022
Study Start
March 1, 2022
Primary Completion
August 31, 2024
Study Completion
August 31, 2024
Last Updated
December 15, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share