RECRUITING

Wide-Area Transepithelial Sampling in Endoscopic Eradication Therapy for Barrett's Esophagus

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

Esophageal cancer is a deadly disease that is becoming increasingly common in the United States. Barrett's esophagus (BE) is a pre-cancerous state that can develop into esophageal cancer, but is highly treatable. Progression of BE to esophageal cancer is still common due to missed diagnosis of Barrett's esophagus recurrence following treatment. Wide-Area Trans-Epithelial Sampling (WATS-3D) is a new technology that uses brush sampling to examine larger areas of the esophagus as compared to conventional biopsies. Preliminary studies show improved detection of cancerous changes in Barrett's esophagus surveillance. The investigators hope to see if the addition of WATS-3D increases the rate of detection of recurrent BE following treatment, which is of the utmost importance since it would allow for earlier re-treatment of disease and ultimately allow for prevention of progression to esophageal cancer.

Official Title

Additive Value of Wide-Area Transepithelial Sampling (WATS3D) in Detection of Recurrence of Intestinal Metaplasia Following Endoscopic Eradication Therapy (EET) for Barrett's Esophagus-Related Neoplasia

Quick Facts

Study Start:2020-10-01
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05056051

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. * All patients aged 18+ diagnosed with Barrett's esophagus with confirmed histologic dysplasia or intra-mucosal cancer undergoing surveillance after EET
  2. * Patients who have achieved CE-IM on at least one surveillance endoscopy following EET
  3. * All subjects must have given signed, informed consent prior to registration in the study
  1. * All patients who are unable or unwilling to give consent will not be included in the study
  2. * All patients deemed to have refractory BE despite EET
  3. * Patients who are pregnant, vulnerable populations such as prisoners, life expectancy \< 1 year based on concurrent comorbidities, coagulopathy with INR \> 1.5 that cannot be reversed, thrombocytopenia with platelets \< 125,000 that cannot be corrected with blood products, unable to safely undergo elective endoscopy due to current comorbidities, and inability to pass standard endoscope will not be included in the study

Contacts and Locations

Study Contact

Srinadh Komanduri, MD, MS
CONTACT
3126950484
skomandu@nm.org
Domenico AJ Farina, MD
CONTACT
3129144602
domenico.farina@northwestern.edu

Principal Investigator

Srinadh Komanduri
PRINCIPAL_INVESTIGATOR
Feinberg School of Medicine

Study Locations (Sites)

University of California, LA
Los Angeles, California, 90095
United States
University of Colorado
Aurora, Colorado, 80045
United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States
Washington University in St. Louis, Barnes Jewish Hospital
Saint Louis, Missouri, 63110
United States

Collaborators and Investigators

Sponsor: Northwestern University

  • Srinadh Komanduri, PRINCIPAL_INVESTIGATOR, Feinberg 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 Date2020-10-01
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2020-10-01
Study Completion Date2025-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Barrett Esophagus
  • Esophageal Cancer