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Non-endoscopic Esophageal Sampling to Detect Barrett's Esophagus and Esophageal Cancer in Veterans

NCT05210049 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2022-12-15

No results posted yet for this study

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.

Conditions

  • Barrett Esophagus
  • GERD
  • Obesity
  • Esophageal Cancer

Interventions

DIAGNOSTIC_TEST

Esocheck/Esoguard

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.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Louis Stokes VA Medical Center

    lead FED

Principal Investigators

  • Katarina B Greer, MD/MS · Louis Stokes Cleveland VA Medical Center

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2024-08-31
Completion
2024-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05210049 on ClinicalTrials.gov