Lucid Registry Study

Recruiting

• Conditions: Barretts Esophagus With Dysplasia; Barrett's Esophagus Without Dysplasia; Barrett Esophagus; Esophageal Adenocarcinoma

• Registration Number: NCT05965999
• Lead Sponsor: Lucid Diagnostics, Inc.

Brief Summary

This is a multicenter, prospective, observational study designed to capture a limited set of data consisting of diagnostic test results and clinical management information on subjects who undergo EC/EG to assess for the presence of BE/EAC. Once sufficient time has elapsed for EsoGuard results to be available, as well as for any subsequent clinical evaluation to have been performed (e.g., upper endoscopy and any initial therapeutic management), study staff will obtain the desired information and record it in an electronic data collection (EDC) system, pertaining to subject demographics, pertinent medical history, and risk factors for BE or EAC as well as (1) information about the EsoCheck cell collection procedure and patient tolerance, (2) EsoGuard test result; (3) initial clinical management including upper endoscopy, if performed, and diagnosis (as determined by the endoscopist and the pathologist assessing any biopsies taken), as well as (4) additional clinical management and/or a therapeutic procedure(s) performed. The time point for collecting such information shall be fluid, depending on the time course of care provided subsequent to the EsoGuard result being available. It is expected typically to be approximately 4 months given the systemic delays in scheduling and performing upper endoscopies and obtaining biopsy results. There is no a priori limit on the timeline for obtaining these data, but it is . anticipated that all data collection will be completed within 8 months of the availability of EsoGuard results.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-23
• Study Start: 2023-04-11
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-20
• Last Update Submitted: 2023-07-20
• Study First Posted: 2023-07-28
• Last Update Posted: 2023-07-28
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Males and Females who have provided informed consent for prospective registry participation
2. Subject in whom the clinical decision has been made to screen for BE/EAC using EsoGuard testing on samples collected with EsoCheck

Exclusion Criteria

1. Inability to provide written informed consent
2. Subjects who fall outside the eligible population defined by the EsoCheck device Instructions For Use (IFU)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Agreement between positive EsoGuard test results and upper endoscopy diagnosis (i.e., subjects with BE/EAC newly diagnosed by upper endoscopy)	Through study completion, an average of 1 year

Secondary Outcome Measures

Name	Time	Method
Agreement between negative EsoGuard test results and upper endoscopy diagnosis (i.e., subjects determined not to have BE/EAC on upper endoscopy)	Through study completion, an average of 1 year
The number of subjects with a positive EsoGuard test	Through study completion, an average of 1 year

Trial Locations

Locations (1)

LUCID DX; 🇺🇸 Lake Forest, California, United States