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A Study of Barrett's Esophagus Patients to Investigate Quality of Life and Fear of Cancer, and Optimize a Risk Model Based on Biomarkers and New Technologies to Better Predict the Development of Cancer

Study acronym: Endeavor-1
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 24, 2026 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Primary completion date: Dec 2025 to Apr 2026v4 Show 4 more changesShow less
    • Study completion date: Dec 2026 to Dec 2027
    • Start date changed from estimate of Jul 2025 to Aug 13, 2025
    • Site details revised at 5 of 9 sites
    • Collaborators revised (16)
  2. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 5 more changesShow less
    • Start date: Nov 2024 to Jul 2025
    • Study sites: 10 to 9
    • Primary completion date: Nov 2025 to Dec 2025
    • Study completion date: Nov 2026 to Dec 2026
    • Study description expanded, about 22 words
  3. Notable Start date: Sep 2024 to Nov 2024
    • Study description expanded, about 8 words
    • Study title expanded, about 1 word
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study serves, in part, to prepare for a future large cohort study. The goal of the study is: 1. The collection of various tissue samples (blood, biopsies and "esophageal brushes") and their analysis. 2. To set up standardized methods for different genetic analyses (DNA-FISH and so-called single cell sequencing) on the esophageal tissue samples. 3. Evaluating the quality of life of Barrett's Esophagus patients and the degree of fear of getting cancer. Patients with a Barrett's Esophagus can participate in the study if they are minimally 18 years old, are capable of giving informed consent (fully understanding what the study entails before giving consent to participate), have Barrett Esophagus and are referred to one of the participating centers due to suspicion of high-grade dysplasia or early esophageal cancer, for which the participant will be evaluated by endoscopic imaging and biopsy. Study procedures: * An intake consultation will be planned, wherein the eligibility criteria will be assessed, and participant characteristics will be collected. * A routine gastroscopy will be planned twice during which several minimally-invasive interventions will be performed: drawing a blood sample, brush cytology during the endoscopy (a brush is used to obtain cells from the surface of the esophagus) and obtaining biopsy samples (small pieces of tissue). Each participant will need to undergo all the interventions. * Patients will have to complete questionnaires at three time points to assess their quality of life (EQ-5D-DL questionnaire) and fear of cancer recurrence (Cancer Worry Scale).
Trial Details
NCT Number NCT06523374
Lead Sponsor University Hospital, Antwerp
Collaborators: Karolinska Institutet, Universal Diagnostics, Amsterdam UMC, Radboud University Medical Center, AZ Delta, University of Leipzig, IRCCS Ospedale San Raffaele, Karolinska University Hospital, University of Dublin, Trinity College, Heinrich-Heine University, Duesseldorf, GZA Ziekenhuizen Campus Sint-Augustinus, University Hospital, Ghent, Rigshospitalet, Denmark, Universitätsklinikum Leipzig, St. James's Hospital, Ireland, University Hospital, Lille
Conditions
(from sponsor)
Barrett's Esophagus, Esophageal Adenocarcinoma
Related terms Adenocarcinoma Of Esophagus, Barrett Esophagus, Esophageal Neoplasms
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov