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

Primary Purpose

Barrett Esophagus, Barretts Esophagus With Dysplasia, Esophagus Adenocarcinoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EsoGuard
Sponsored by
Lucid Diagnostics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Barrett Esophagus

Eligibility Criteria

12 Years - 99 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arkansas Heartburn Treatment CenterRecruiting
  • Arvada West Family Medicine,Recruiting
  • Colorado Primary HealthcareRecruiting
  • Savii HealthRecruiting
  • James E RaceRecruiting
  • Texas Digestive Specialists
  • Gastroenterology Partners of North Houston, PLLCRecruiting
  • Premier Family Medical

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Arm Study

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 25, 2023
Last Updated
September 6, 2023
Sponsor
Lucid Diagnostics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06030180
Brief Title
CLUE: CLinical Utility Study of EsoGuard
Acronym
PR-0410
Official Title
CLUE: CLinical Utility Study of EsoGuard on Samples Collected Using EsoCheck as a Triage Test for Endoscopy to Identify Barrett's Esophagus (BE)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2023 (Actual)
Primary Completion Date
September 29, 2023 (Anticipated)
Study Completion Date
September 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lucid Diagnostics, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett Esophagus, Barretts Esophagus With Dysplasia, Esophagus Adenocarcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Arm Study
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
EsoGuard
Other Intervention Name(s)
EsoGuard test on cells collected using EsoCheck
Intervention Description
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)
Primary Outcome Measure Information:
Title
Clinical Utility
Description
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 Outcome Measure Information:
Title
Patient Compliance
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexa Rueda
Phone
9157405766
Email
axr@pavmed.com
First Name & Middle Initial & Last Name or Official Title & Degree
Karyms Luna Miller
Email
klm@pavmed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gisella Lopez
Organizational Affiliation
Lucid Diagnostics
Official's Role
Study Director
Facility Information:
Facility Name
Arkansas Heartburn Treatment Center
City
Heber Springs
State/Province
Arkansas
ZIP/Postal Code
72543
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beth Lister
Facility Name
Arvada West Family Medicine,
City
Arvada
State/Province
Colorado
ZIP/Postal Code
80004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Doanes
Facility Name
Colorado Primary Healthcare
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ken Dole
Facility Name
Savii Health
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wendy Blakenship
Facility Name
James E Race
City
Dallas
State/Province
Texas
ZIP/Postal Code
75224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yolanda Torres
Facility Name
Texas Digestive Specialists
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Olvera
Facility Name
Gastroenterology Partners of North Houston, PLLC
City
Shenandoah
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erica Warren
Facility Name
Premier Family Medical
City
Lindon
State/Province
Utah
ZIP/Postal Code
84042
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Esquivel

12. IPD Sharing Statement

Plan to Share IPD
No

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CLUE: CLinical Utility Study of EsoGuard

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