Clinical trial NCT03015389: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Barrett Esophagus
Esophageal Dysplasia
Esophageal Adenocarcinoma
Lead sponsor: CDx Diagnostics
Sponsor class: INDUSTRY
First posted: 2017-01-10
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Barrett's associated esophageal dysplasia

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: up to 2 years
Secondary outcomes:
measure: Number of participants with Barrett's related dysplasia and adenocarcinoma diagnosed with random forceps biopsies and WATS3D biopsies used in alternating fashion.
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven - Campus Gasthuisberg
Study officials:
affiliation: University Hospitals Leuven, Dept. of Gastroenterology
name: Raf Bisschops, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nuovo Regina Margherita Hospital
name: Cesare Hassan, MD
role: PRINCIPAL_INVESTIGATOR
References: