Actively Recruiting
A Multicenter Prospective Cohort Study Comparing Random Biopsies Versus Wide-Area Transepithelial Brush-Sampling (WATS) for Surveillance of Barrett's Esophagus, the WATS-EURO2 Study
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2022-12-08
416
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The investigators aim to study the rate of developing a biopsy-based diagnosis of high-grade dysplasia (HGD) and EAC in BE patients in a prospective cohort of 208 BE patients at high risk of progression (i.e. after endoscopic removal of visible lesions containing HGD/EAC and/or a diagnosis of low-grade dysplasia (LGD)) as well as in 208 BE patients with a nondysplastic BE (NDBE) undergoing standard BE surveillance. In these patients the investigators will combine biopsy sampling with WATS at baseline and all follow-up endoscopies during a 3- year follow-up period. This will allow us to study the natural history of WATS-positive-biopsynegative- cases and of WATS-specific outcomes such as basal-crypt dysplasia. The study also allows us to collect specimens for future biomarker studies that may help to predict progression to HGD/EAC in the absence of morphological features of dysplasia.
CONDITIONS
Official Title
A Multicenter Prospective Cohort Study Comparing Random Biopsies Versus Wide-Area Transepithelial Brush-Sampling (WATS) for Surveillance of Barrett's Esophagus, the WATS-EURO2 Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Barrett's Esophagus with circumferential extent of 2 cm or more and total maximum extent up to 18 cm, or circumferential extent of 0-1 cm with total maximum extent up to 4 cm
- Patients referred for evaluation of indefinite, low-grade, or high-grade dysplasia, or low-risk esophageal cancer diagnosed by biopsy or endoscopic resection within 18 months prior to baseline
- Patients with known Barrett's Esophagus without dysplasia diagnosis in the last 18 months enrolled in surveillance programs
- Ability to provide written informed consent and understand study participation
You will not qualify if you...
- Presence of visible esophageal lesions at time of testing (prior endoscopic resection allowed)
- High-risk esophageal cancer after endoscopic resection with sm2/3 invasion, poor differentiation, lympho-vascular invasion, or positive vertical resection margin
- Endoscopy with biopsies or endoscopic resection within the past six weeks
- History of esophageal or gastric surgery other than Nissen fundoplication
- History of esophageal ablation therapy
- Presence of esophageal varices
- Known unresolved drug or alcohol dependency limiting ability to consent or follow study instructions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Amsterdam University Medical Centre, loc. VUmc
Amsterdam, North Holland, Netherlands, 1081HV
Actively Recruiting
Research Team
P
Pim Stougie
CONTACT
L
Lucas C Duits, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here