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NCT06523374Recruiting

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

Endoscopic Brush Cytology and Single Cell Clonal Dynamics of Early Esophageal Adenocarcinoma for Defining Cost Effective Surveillance Strategies and Prediction of Cancer Recurrence: Prospective Pilot Cohort Study in Preparation of a Randomized Controlled Trial to Determine the Feasibility of a Risk Stratification Model for Barrett Esophagus Patients Based on Brush Cytology, and to Test Novel High Throughput Methods for Assessing Biomarkers for Future Use

Source: ClinicalTrials.gov · Last updated 24 Feb 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Study type
Interventional
Enrollment
50 (estimated)
First submitted
17 Jun 2024
Start date
13 Aug 2025
Primary completion date
Apr 2026
Lead sponsor
University Hospital, Antwerp
NCT number
NCT06523374

What you commit to

  • Study type: Interventional
  • Planned participants: 50
  • From 13 Aug 2025 to the primary completion date, Apr 2026
  • 9 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Undergoing chemotherapy or immunotherapy or received chemotherapy \< 6 weeks prior to endoscopy
  • Undergoing radiotherapy within the esophageal region or received chemotherapy \< 6 months prior to endoscopy

Other illness

  • Patients with current known malignancy of the gastrointestinal tract other than the esophageal lesion
  • Patients with severe co-morbidity that prohibits endoscopic therapy under sedation or conscious sedation (such as severe cardiac or pulmonary disease)
  • Uncontrollable coagulation disorders

Other

  • Esophageal varices
  • WHO score \> 3

Who the study is looking for

  • Patients with known BE undergoing endoscopy for possible treatment by EMR or ESD due to suspicion of early esophageal Barrett cancer
  • Capable of receiving informed consent and of giving permission
  • Age 18 and upward

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital Antwerp
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EdegemBelgiumRecruiting
UZ Gent
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GhentBelgiumRecruiting
AZ Delta
Coordinator of this site? Confirm its status
RoeselareBelgiumRecruiting
Sint-Augustinus Hospital (ZAS)
Coordinator of this site? Confirm its status
WilrijkBelgiumRecruiting
Rigshospitalet
Coordinator of this site? Confirm its status
CopenhagenDenmarkRecruiting
CHU LILLE - Centre Hospitalier Universitaire de Lille
Coordinator of this site? Confirm its status
LilleFranceRecruiting
St. James's Hospital
Coordinator of this site? Confirm its status
DublinIrelandRecruiting
IRCCS Ospedale San Raffaele
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Karolinska University Hospital
Coordinator of this site? Confirm its status
SolnaSwedenRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.