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

NCT03015389 | Completed

• 1 other identifier: CDx 810
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Barrett Esophagus; Esophageal Dysplasia; Esophageal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Barrett's associated esophageal dysplasia

Procedure: Diagnostic Test

Interventions

Diagnostic Test PROCEDURE

WATS3D brush biopsy

Barrett's associated esophageal dysplasia

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's associated esophageal dysplasia

You may qualify if:

• Patients age: ≥ 18 years
• Patients should have a history of Barrett's associated esophageal dysplasia (either low or high-grade) confirmed on histology
• Willingness to undergo both WATS3D and random forceps biopsies while undergoing conventional EGD with sedation
• Ability to provide written, informed consent (approved by IRB) and understand the responsibilities of trial participation
• 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

You may not qualify if:

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

Sponsors & Collaborators

• CDx Diagnostics: lead

Study Sites (1)

UZ Leuven - Campus Gasthuisberg

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Barrett Esophagus; Adenocarcinoma Of Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Raf Bisschops, MD

  University Hospitals Leuven, Dept. of Gastroenterology

  PRINCIPAL INVESTIGATOR

• Cesare Hassan, MD

  Nuovo Regina Margherita Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: January 10, 2017
• Study Start: September 27, 2017
• Primary Completion: February 18, 2019
• Study Completion: February 18, 2019
• Last Updated: July 23, 2020

Record last verified: 2020-07

Locations

BE (1)