Clinical trial NCT04312633: Clinical Utility of WATS3D: A 5-Year Prospective Study
Official title: CDx Study 906: The Clinical Utility of WATS3D (Wide Area Transepithelial Sampling With Computer-Assisted 3-Dimensional Analysis): A 5- Year Prospective Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Barrett Esophagus
Gastro Esophageal Reflux
Esophageal Dysplasia
Esophageal Diseases
Lead sponsor: CDx Diagnostics
Sponsor class: INDUSTRY
First posted: 2020-03-18
Enrollment: 90000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Patients with heartburn or regurgitation undergoing a screening EGD, who undergo WATS3D sampling and forceps biopsies for suspicion of BE, or
* Patients with known BE with or without dysplasia undergoing a surveillance EGD with WATS3D biopsies and forceps biopsies, or
* Patients who have undergone endoscopic eradication (i.e. radiofrequency ablation or cryoablation) who are undergoing surveillance EGD following the establishment of complete eradication of intestinal metaplasia (CEIM)

Brief summary: The purpose of this study is to create a registry (collect data and keep it in a research database) to learn more about two methods of taking small tissue samples from your esophagus (the esophagus is the tube that carries food and liquid from your mouth to your stomach). The two methods of sampling are: 1) Using forceps that take biopsies (small tissue samples) from your esophagus, and 2) Using a brush that also takes biopsies from your esophagus.

Detailed description: This study will look at the impact of the brush biopsy results on your doctor's decisions about your future care and treatment.

In addition , by recording the results of all your biopsies over 5 years, it may be possible to find out if the brush biopsy, forceps biopsy, or both can predict which patients with heartburn develop Barrett's esophagus, (an abnormality in the esophagus that may lead to cancer), and which patients with Barrett's esophagus develop precancer and cancer.

You are being asked to participate in the study because you are receiving an upper endoscopy (a procedure where a tube with a light and camera are inserted in your mouth and down your throat) with forceps and brush biopsies of your esophagus as part of you standard clinical care, and you are at least 18 years old.

Eligibility criteria: Inclusion Criteria:

* Able to read, comprehend and complete the IRB-approved consent form
* Aged 18 or older
* Meet one of the following:
* Patients with heartburn or regurgitation undergoing a screening EGD, who undergo WATS3D sampling and forceps biopsies for suspicion of BE, or
* Patients with known BE with or without dysplasia undergoing a surveillance EGD with WATS3D biopsies and forceps biopsies, or
* Patients who have undergone endoscopic eradication (i.e. radiofrequency ablation or cryoablation) who are undergoing surveillance EGD following the establishment of complete eradication of intestinal metaplasia (CEIM)
* Only patients who undergo both forceps biopsies and WATS3D of the esophagus will be included.

Exclusion Criteria:

* Pregnancy at time of endoscopy
* Unresolved drug or alcohol dependency that will limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions or follow-up guidelines
* Medical condition that will likely prohibit completion of a 5 year study

Primary outcomes:
measure: Primary Outcome Measure:
timeFrame: 5 years
Secondary outcomes:
measure: Secondary Outcome Measure:
timeFrame: 5 years
Other outcomes:
Locations:
city: Bethpage
country: United States
facility: NYU Langone Ambulatory Care
state: New York
Study officials:
affiliation: NYU Langone Health
name: Matthew McKinley, M.D.
role: PRINCIPAL_INVESTIGATOR
References: