CLUE: CLinical Utility Study of EsoGuard (PR-0410)

September 6, 2023 updated by: Lucid Diagnostics, Inc.

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arkansas
      • Heber Springs, Arkansas, United States, 72543
        • Recruiting
        • Arkansas Heartburn Treatment Center
        • Contact:
          • Beth Lister
    • Colorado
      • Arvada, Colorado, United States, 80004
        • Recruiting
        • Arvada West Family Medicine,
        • Contact:
          • Laura Doanes
      • Littleton, Colorado, United States, 80120
        • Recruiting
        • Colorado Primary Healthcare
        • Contact:
          • Ken Dole
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Recruiting
        • Savii Health
        • Contact:
          • Wendy Blakenship
    • Texas
      • Dallas, Texas, United States, 75224
        • Recruiting
        • James E Race
        • Contact:
          • Yolanda Torres
      • Harlingen, Texas, United States, 78550
        • Not yet recruiting
        • Texas Digestive Specialists
        • Contact:
          • Roberto Olvera
      • Shenandoah, Texas, United States, 77384
        • Recruiting
        • Gastroenterology Partners of North Houston, PLLC
        • Contact:
          • Erica Warren
    • Utah
      • Lindon, Utah, United States, 84042
        • Not yet recruiting
        • Premier Family Medical
        • Contact:
          • Laura Esquivel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single Arm Study
Device: EsoGuard
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lucid Diagnostics, Inc.

Investigators

  • Study Director: Gisella Lopez, Lucid Diagnostics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2023

Primary Completion (Estimated)

September 29, 2023

Study Completion (Estimated)

September 29, 2023

Study Registration Dates

First Submitted

August 25, 2023

First Submitted That Met QC Criteria

September 6, 2023

First Posted (Actual)

September 8, 2023

Study Record Updates

Last Update Posted (Actual)

September 8, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR-0410

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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