CLUE: CLinical Utility Study of EsoGuard

Lucid Diagnostics, Inc.566 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

566

Conditions

Barrett Esophagus Barretts Esophagus With Dysplasia Esophagus Adenocarcinoma

Interventions

EsoGuardDEVICE

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)

Eligibility

Sex: ALLMin age: 12 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Individuals in whom the clinical decision has been made to screen for BE using EC/EG 2. 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: 1. Individuals who fall outside the eligible population defined by the EsoCheck device Instructions For Use (IFU) 2. Individuals who do not meet either the ACG or AGA guidelines/practice advice for BE screening 3. Inability to provide written informed consent or participate in the required follow up

Locations (8)

Arkansas Heartburn Treatment Center

Heber Springs, Arkansas, United States

Arvada West Family Medicine,

Arvada, Colorado, United States

Colorado Primary Healthcare

Littleton, Colorado, United States

Savii Health

Savannah, Georgia, United States

Outcomes

Primary Outcomes

Clinical Utility

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.

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

Secondary Outcomes

Patient Compliance

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.

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

Data from ClinicalTrials.gov

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