Using tissue, brush, and blood tests to improve cancer risk prediction and quality of life tracking in Barrett's Esophagus
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
NA · University Hospital, Antwerp · NCT06523374
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.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Antwerp (other) |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 9 sites (Edegem, Antwerpen and 8 other locations) |
| Trial ID | NCT06523374 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Edegem, Antwerpen and 8 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Barrett's Esophagus, Esophageal Adenocarcinoma, Barrett, Endeavor, Esophageal cancer, Esophageal adenocarcinoma