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Clinical trial Recruiting at 9 sites Interventional Ages 18 and up

Using tissue, brush, and blood tests to improve cancer risk prediction and quality of life tracking in Barrett's Esophagus

Official title: 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

Run by University Hospital, Antwerp · NCT06523374 · Data updated 2026-11-12

This will try extra biopsies, esophageal brushings, blood tests, and short questionnaires to see if they can better predict cancer risk and track quality of life for adults with Barrett's Esophagus who are being evaluated for possible early cancer.

More Esophageal Adenocarcinoma trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment50 (estimated)
SponsorUniversity Hospital, Antwerp
Academic / other
Drugs / interventionschemotherapy, immunotherapy
Locations9 sites (Edegem, Antwerpen and 8 other locations)
StatusRecruiting
StartedAugust 13, 2025
Main results expectedApril 2026
Study endsDecember 2027
Registry record updatedFebruary 24, 2026
Trial IDNCT06523374 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18+) with known Barrett's Esophagus who are referred for endoscopy because of suspected high-grade dysplasia or early esophageal cancer and who can give informed consent.

Probably not a fit

People without Barrett's Esophagus, those with other active gastrointestinal malignancies, patients with severe comorbidities that prevent endoscopy under sedation, those with uncontrolled coagulation disorders, or patients recently receiving chemotherapy or radiotherapy are unlikely to benefit or may be ineligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study collects additional esophageal biopsies, four esophageal brush samples, and blood tubes during routine endoscopies, and asks participants to complete brief mobile questionnaires about quality of life and fear of cancer. Samples will be analyzed using standardized genetic methods including DNA-FISH and single-cell sequencing to develop and optimize a biomarker-based risk model. Participation involves a screening visit and two sample-collection visits that coincide with scheduled care, adds about 10–15 minutes to endoscopy time, and includes outcome follow-up during routine visits for up to five years. The work is intended to prepare methods and data for a future larger cohort study to improve prediction of progression to esophageal cancer.

Why it matters

Potential benefit: If successful, this could help doctors identify which patients with Barrett's Esophagus are most likely to develop cancer so surveillance and treatment can be better targeted.

How similar studies have gone: Biomarker-based risk models in Barrett's Esophagus have shown promise, but combining DNA-FISH and single-cell sequencing in this context is relatively new and not yet proven in large cohorts.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* Esophageal varices
* Uncontrollable coagulation disorders
* 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
* WHO score \> 3

Where it's running

  • University Hospital Antwerp
    Edegem, Antwerpen, Belgium     Recruiting
  • Sint-Augustinus Hospital (ZAS)
    Wilrijk, Antwerpen, Belgium     Recruiting
  • UZ Gent
    Ghent, Belgium     Recruiting
  • AZ Delta
    Roeselare, Belgium     Recruiting
  • Rigshospitalet
    Copenhagen, Denmark     Recruiting
  • CHU LILLE - Centre Hospitalier Universitaire de Lille
    Lille, France     Recruiting
Show 3 more locations
  • St James's Hospital
    Dublin, Ireland     Recruiting
  • IRCCS Ospedale San Raffaele
    Milan, Milano, Italy     Recruiting
  • Karolinska University Hospital
    Solna, Sweden     Recruiting

Study contacts

  • Principal investigator: Sheila Krishnadath — Universitair Ziekenhuis Antwerpen (UZA)
  • Study coordinator: Toon Mertens
  • Email: Toon.mertens@uza.be
  • Phone: +3234368281

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Barrett's Esophagus 9Esophageal Adenocarcinoma 67University Hospital, Antwerp 44
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.