CLUE: CLinical Utility Study of EsoGuard

Utilize real-world data from the commercial use of EsoGuard testing on samples collected with EsoCheck (EC/EG) to evaluate the impact of EsoGuard results on health care provider's decision for endoscopy referral. Assess patient compliance with recommendations for upper endoscopy, and relationship of compliance to positive EsoGuard results.

Completed

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Key information

Conditions

Barrett Esophagus Adenocarcinoma Of Esophagus Barretts Esophagus With Dysplasia Digestive System Diseases Esophageal Diseases Esophagus Adenocarcinoma Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

12 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arkansas Heartburn Treatment Center, Heber Springs, Arkansas, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Individuals in whom the clinical decision has been made to screen for BE using EC/EG
Individuals who meet criteria for BE screening in accordance with either the 2022 ACG guidelines, or the AGA best practice advice from their 2022 clinical practice update.

Exclusion criteria

Individuals who fall outside the eligible population defined by the EsoCheck device Instructions For Use (IFU)
Individuals who do not meet either the ACG or AGA guidelines/practice advice for BE screening
Inability to provide written informed consent or participate in the required follow up

Treatment and study plan

EsoGuard

Device

EsoGuard is a set of genetic assays and algorithms for the assessment of specific methylation patterns of DNA encoding the genes vimentin (VIM) and cyclin A1 (CCNA1)

Other names: EsoGuard test on cells collected using EsoCheck

Primary outcomes

Clinical Utility

Time frame: Through study completion, an average of 1 year

Utilize real-world data from the commercial use of EsoGuard testing on samples collected with EsoCheck (EC/EG) to evaluate the impact of EsoGuard results on health care provider's decision for endoscopy referral. This will be measured by asking physicians how the EsoGuard result impacted their referral decision.

Secondary outcomes

Patient Compliance

Time frame: Through study completion, an average of 1 year

Assess patient compliance with recommendations for upper endoscopy, and relationship of compliance to positive EsoGuard results. This will be measured by collecting data on whether patients received an endoscopy after being referred.

Sponsors and collaborators

Lead sponsor

Lucid Diagnostics, Inc.

Industry

Registry information

Official study title

CLUE: CLinical Utility Study of EsoGuard on Samples Collected Using EsoCheck as a Triage Test for Endoscopy to Identify Barrett's Esophagus (BE)

Acronym: PR-0410

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Sep 8, 2023
Registry last updated: Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed