RECRUITING

Clinical Utility of WATS3D: A 5-Year Prospective Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2020-04-01
Study Completion:2027-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04312633

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able to read, comprehend and complete the IRB-approved consent form
  2. * Aged 18 or older
  3. * Meet one of the following:
  4. * Patients with heartburn or regurgitation undergoing a screening EGD, who undergo WATS3D sampling and forceps biopsies for suspicion of BE, or
  5. * Patients with known BE with or without dysplasia undergoing a surveillance EGD with WATS3D biopsies and forceps biopsies, or
  6. * 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)
  7. * Only patients who undergo both forceps biopsies and WATS3D of the esophagus will be included.
  1. * Pregnancy at time of endoscopy
  2. * 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
  3. * Medical condition that will likely prohibit completion of a 5 year study

Contacts and Locations

Study Contact

Karen Hoffman, M.D.
CONTACT
845-777-7000
khoffman@cdxdiagnostics.com
William Cuddy
CONTACT
845-368-7452
wcuddy@cdxdiagnostics.com

Principal Investigator

Matthew McKinley, M.D.
PRINCIPAL_INVESTIGATOR
NYU Grossman School of Medicine

Study Locations (Sites)

NYU Langone Ambulatory Care
Bethpage, New York, 11714
United States

Collaborators and Investigators

Sponsor: CDx Diagnostics

  • Matthew McKinley, M.D., PRINCIPAL_INVESTIGATOR, NYU Grossman School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-04-01
Study Completion Date2027-11-01

Study Record Updates

Study Start Date2020-04-01
Study Completion Date2027-11-01

Terms related to this study

Additional Relevant MeSH Terms

  • Barrett Esophagus
  • Gastro Esophageal Reflux
  • Esophageal Dysplasia
  • Esophageal Diseases