COMPLETED

CLUE: CLinical Utility Study of EsoGuard

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. Assess patient compliance with recommendations for upper endoscopy, and relationship of compliance to positive EsoGuard results.

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)

Quick Facts

Study Start:2023-02-23
Study Completion:2024-12-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06030180

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.

Ages Eligible for Study:12 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Individuals in whom the clinical decision has been made to screen for BE using EC/EG
  2. 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.
  1. 1. Individuals who fall outside the eligible population defined by the EsoCheck device Instructions For Use (IFU)
  2. 2. Individuals who do not meet either the ACG or AGA guidelines/practice advice for BE screening
  3. 3. Inability to provide written informed consent or participate in the required follow up

Contacts and Locations

Principal Investigator

Gisella Lopez
STUDY_DIRECTOR
Lucid Diagnostics

Study Locations (Sites)

Arkansas Heartburn Treatment Center
Heber Springs, Arkansas, 72543
United States
Arvada West Family Medicine,
Arvada, Colorado, 80004
United States
Colorado Primary Healthcare
Littleton, Colorado, 80120
United States
Savii Health
Savannah, Georgia, 31406
United States
James E Race
Dallas, Texas, 75224
United States
Texas Digestive Specialists
Harlingen, Texas, 78550
United States
Gastroenterology Partners of North Houston, PLLC
Shenandoah, Texas, 77384
United States
Premier Family Medical
Lindon, Utah, 84042
United States

Collaborators and Investigators

Sponsor: Lucid Diagnostics, Inc.

  • Gisella Lopez, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2023-02-23
Study Completion Date2024-12-13

Study Record Updates

Study Start Date2023-02-23
Study Completion Date2024-12-13

Terms related to this study

Additional Relevant MeSH Terms

  • Barrett Esophagus
  • Barretts Esophagus With Dysplasia
  • Esophagus Adenocarcinoma