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

NCT05642338 | Recruiting DMC FDA Device

• 1 other identifier: NL81868.018.22
• Study Type: observational
• Target: 416
• Locations: 1 country
• Sites: 1

Brief Summary

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

Barrett Esophagus; Esophageal Adenocarcinoma; Diagnosis

Keywords

detection; Barrett Esophagus; WATS3D; forceps Biopsies; Dysplasia

Outcome Measures

Primary Outcomes (1)

• HGD/EAC

  The concordance/discordance for the diagnosis HGD/EAC between random biopsies and WATS brushings collected at the baseline endoscopy and follow-up endoscopies.

  3 years after last inclusion

Secondary Outcomes (2)

• The proportion of patients diagnosed with HGD/EAC on endoscopic biopsies (targeted or random) or endoscopic resection specimens during a maximum follow-up of 3 years

  3 years after last inclusion

• The rate of progression to HGD/EAC after a WATS-positive-biopsy-negative diagnosis for HGD/EAC

  3 years after last inclusion

Study Arms (2)

cohort 1 dysplastic cohort

208 BE patients referred for work up after diagnosis of LGD, HGD or earlystage cancer in the last 18 months.

Diagnostic Test: WATS3D

Cohort 2: non-dysplastic cohort

208 patients under standard BE surveillance without a diagnosis of dysplasia in last 18 months.

Diagnostic Test: WATS3D

Interventions

WATS3D DIAGNOSTIC_TEST

the WATS3D brush samples the esophagus by abresing the tissue. the brush is directed through the workingchanel of endoscope into the oesophagus

Also known as: CDxx WATS3D brush

Cohort 2: non-dysplastic cohort; cohort 1 dysplastic cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Barrett Esophagus patient enrolled in a surveillance cohort

You may qualify if:

• Patients age: ≥ 18 years
• BE with a circumferential extent of ≥2cm and a total maximum extent of ≤18cm (in case of prior ER: BE length is measured after ER). Or a circumferential extent of 0-1 cm with a maximum extent of ≥4cm.
• Cohort 1: Patients referred for work-up of IND, LGD, HGD or low-risk cancer (m1 to sm1, without lympho-vascular invasion and poor differentiation), either diagnosed in random biopsies or in prior endoscopic resection specimen within 18 months prior to baseline endoscopy
• Cohort 2: Patients with known BE without a diagnosis of dysplasia in the last 18 months, enrolled in endoscopic surveillance programs
• Ability to give written, informed consent and understand the responsibilities of participation

You may not qualify if:

• Patients with visible lesions according to the Paris classification at the time of the WATS and random biopsy testing (prior endoscopic resection is allowed)
• Patients with high-risk cancer after endoscopic resection: either sm2/3 invasion, poor differentiation, lympho-vascular invasion, or R1 vertical resection margin
• Patients within six weeks after endoscopy with biopsies and/or ER
• History of esophageal or gastric surgery other than Nissen fundoplication
• History of esophageal ablation therapy
• Presence of esophageal varices
• Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam University Medical Centre, loc. VUmc

Amsterdam, North Holland, 1081HV, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

samples of the distal barrett mucosa in the oesophagus collected with forceps biopsies and the WATS3D brush

MeSH Terms

Conditions

Barrett Esophagus; Adenocarcinoma Of Esophagus; Disease

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• prof Bergman, MD, PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pim Stougie

CONTACT

+31617741850; l.c.duits@amsterdamumc.nl

Lucas C Duits, MD, PhD

CONTACT

l.c.duits@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.dr.

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 8, 2022
• Study Start: November 1, 2022
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: December 8, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)