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.
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.
A Multicenter, Prospective, Open-Label Registry Study of the Utilization of EsoGuard, on Samples Collected Using EsoCheck, in an At-Risk Population Undergoing Standard of Care Screening for, and Management of, Previously Undiagnosed Barrett's Esophagus and/or Esophageal Adenocarcinoma
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.
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Sponsor: Lucid Diagnostics, Inc.
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.