Lucid Registry Study

Lucid Diagnostics, Inc.8,000 enrolled

Overview

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. For subjects endoscopically confirmed with intestinal metaplasia, dysplasia, or cancer, the registry will collect additional clinical management and/or a therapeutic procedure(s) performed and other mid- to long-term outcomes. For subjects who are negative for BE/EAC via EsoGuard or negative for BE/EAC via EGD will be offered the option of longer-term follow-up in the form of intermittent wellness checks. 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. Subject participation duration is dependent on EsoGuard results, physician referral, EGD results (if referred) and participation in long-term follow-up. If EG results are negative and subject is not referred for an EGD, participation could last 1 month. If a subject is confirmed with BE/EAC, participation may continue beyond this minimum for an indefinite period, with no predetermined maximum duration.

Study Type

OBSERVATIONAL

Enrollment

8,000

Conditions

Barrett Esophagus Esophageal Adenocarcinoma

Interventions

EsoCheck®DEVICE

EsoCheck® (EC) is an FDA 510(k) cleared device that is indicated for use in the collection and retrieval of surface cells of the esophagus in the general population 12 years of age and older.

EsoGuard®DIAGNOSTIC_TEST

EsoGuard® is a DNA assay which examines for the presence of cytosine methylation at 31 different genomic locations on the vimentin (VIM) and Cyclin-A1 (CCNA1) genes. Using EsoCheck and EsoGuard in combination may offer an accurate, lower cost, non-invasive, approach to screen for Barrett's Esophagus (BE) with and without dysplasia, and for esophageal adenocarcinoma (EAC).

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Individuals in whom a healthcare provider has made the independent clinical decision to screen for BE/EAC (based on assessment of elevated disease risk) using EsoGuard for analysis of cell samples collected with EsoCheck 2. Provided written informed consent for prospective registry participation/data collection 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)

Outcomes

Primary Outcomes

Subsequent Clinical Management Following EsoGuard Testing

Proportion of subjects who undergo a clinically relevant management action following receipt of an EsoGuard result, including referral for esophagogastroduodenoscopy (EGD), surveillance, therapeutic intervention, or other physician-directed management. Clinical management decisions are collected as part of routine clinical care.

Time frame: Up to 12 months following EsoGuard testing

Secondary Outcomes

Endoscopic Confirmation of Barrett's Esophagus and/or Esophageal Neoplasia

Proportion of subjects with a completed EGD and pathology assessment confirming Barrett's esophagus (BE), dysplasia, esophageal adenocarcinoma (EAC), or other relevant esophageal findings following EsoGuard testing.

Time frame: Up to 12 months following EsoGuard testing

Disease Stage at Endoscopic Diagnosis

Histologic and/or clinical stage of Barrett's esophagus, dysplasia, or esophageal neoplasia identified during clinically indicated endoscopic evaluation following EsoGuard testing.

Time frame: Up to 12 months following EsoGuard testing

Therapeutic Interventions Following EsoGuard Testing

Proportion of subjects who undergo therapeutic intervention for BE, dysplasia, or EAC, including endoscopic eradication therapy, surgical intervention, pharmacologic treatment, or other standard-of-care management.

Time frame: Up to 12 months following EsoGuard testing

Surveillance Utilization Following EsoGuard Testing

Proportion of subjects who undergo follow-up surveillance procedures or monitoring for BE/EAC according to routine clinical practice.

Time frame: Up to 24 months following EsoGuard testing

Incident Detection of Barrett's Esophagus or Esophageal Adenocarcinoma

Number and proportion of subjects initially considered negative for BE/EAC who subsequently receive a diagnosis of BE, dysplasia, or EAC during follow-up.

Time frame: Up to 24 months following EsoGuard testing

Disease Progression or Resolution

Among subjects with identified esophageal disease, assessment of disease progression, stability, or resolution based on available endoscopic, histologic, and clinical follow-up data.

Time frame: Up to 24 months following EsoGuard testing

Lucid Registry Study

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts