Wide Area Transepithelial Sample Esophageal Biopsy Combined With Computer Assisted 3-Dimensional Tissue Analysis (WATS3D) For the Detection of High Grade Esophageal Dysplasia and Adenocarcinoma

This is a multi-center, prospective, randomized study which will enroll patients undergoing endoscopic surveillance due to a history of histologically confirmed dysplasia. A member of the research team will approach a potential subject to discuss participation in the study, including background of the proposed study, inclusion and exclusion criteria, benefits and risks of the procedures and follow-up. If this is of interest to the subject, the informed consent form is discussed and presented. The subject must sign the consent form prior to enrollment. This form will have prior approval of the study site's Institutional Review Board (IRB). Failure to obtain informed consent renders the subject ineligible for the study.

Study Overview

• Status: Completed
• Conditions: Barrett Esophagus; Esophageal Adenocarcinoma; Esophageal Dysplasia
• Intervention / Treatment: Procedure: Diagnostic Test

• Study Type: Observational
• Enrollment (Actual): 170

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven - Campus Gasthuisberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Barrett's associated esophageal dysplasia

Description

Inclusion Criteria:

1. Patients age: ≥ 18 years
2. Patients should have a history of Barrett's associated esophageal dysplasia (either low or high-grade) confirmed on histology
3. Willingness to undergo both WATS3D and random forceps biopsies while undergoing conventional EGD with sedation
4. Ability to provide written, informed consent (approved by IRB) and understand the responsibilities of trial participation
5. Only patients who no visible mucosal abnormalities at the time that they undergo both random forceps biopsies and WATS3D testing of the esophagus will be included in this study

Exclusion Criteria:

1. Coagulopathy with INR > 2.0, thrombocytopenia with platelet counts < 50,000
2. The subject is pregnant or planning a pregnancy during the study period
3. History of esophageal or gastric surgery other than Endoscopic Mucosal Resection (EMR)
4. Patients who have undergone endoscopic ablative therapies
5. 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
6. Study patients with inadequate WATS3D specimens will not undergo a repeat brush biopsy test and will be excluded from the study
7. BE length < 1 cm or > 10 cm
8. Patients within six weeks of receiving targeted forceps biopsies and/or EMR
9. Patients with visible mucosal abnormality at the time of the WATS3D and random biopsy testing
10. Patients with visible lesions that are either submucosal or covered with a clinically intact epithelium

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Barrett's associated esophageal dysplasia	Procedure: Diagnostic Test; WATS3D brush biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Detection rate of Barrett's associated high grade esophageal dysplasia and esophageal adenocarcinoma (HGD/EAC) using WATS3D and random 4 quadrant forceps biopsies taken at 2 cm intervals.	up to 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with Barrett's related dysplasia and adenocarcinoma diagnosed with random forceps biopsies and WATS3D biopsies used in alternating fashion.	up to 2 years

Collaborators and Investigators

• Sponsor: CDx Diagnostics
• Investigators: Principal Investigator: Raf Bisschops, MD, University Hospitals Leuven, Dept. of Gastroenterology

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 27, 2017
• Primary Completion (ACTUAL): February 18, 2019
• Study Completion (ACTUAL): February 18, 2019

Study Registration Dates

• First Submitted: January 5, 2017
• First Submitted That Met QC Criteria: January 6, 2017
• First Posted (ESTIMATE): January 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 23, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Adenocarcinoma; Barrett Esophagus
• Other Study ID Numbers: CDx 810