RECRUITING

Barrett's Esophagus Related Neoplasia (BERN) Project

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 use of high resolution endoscopy (HRE), narrow band imaging (NBI) and chromoendoscopy increases the detection rates of Barrett's esophagus (BE) and early neoplasia. * Endoscopic mucosal resection (EMR) will improve the accuracy for detection of dysplasia/early neoplasia. Specific Aim 1 - To create a video-atlas of non-dysplastic and dysplastic/early neoplastic lesions in patients with BE. This will be used for training purposes and to assess learning curve associated with these new technologies. Specific Aim 2 - To create a standardized classification system for the mucosal and vascular patterns observed in patients with BE. Specific Aim 3 - To determine the interobserver agreement using the video-atlas for the mucosal and vascular patterns classification agreed upon. Specific Aim 4 - To determine the endoscopic detection rate of esophageal cancer or precancerous lesions removed during endoscopy. Specific Aim 5 - To determine the pathologic and clinical outcomes of patients undergoing EMR/ablation; including morbidity, mortality and complications of the procedure. Results to date (June 2008) : this study is active and open to enrollment. Currently 26 patients have enrolled in this study at the Kansas City VA medical center. In order to participate, patients must be eligible for care at the KCVA hospital.

Official Title

Endoscopic Detection of Early Neoplasia in Patients With Barrett's Esophagus

Quick Facts

Study Start:2007-05-15
Study Completion:2026-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT00590239

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. * 18-80 years
  2. * Patients must be able to provide written informed consent
  3. * Patients referred for endoscopy for screening/surveillance of BE or for endoscopic treatment of BE with early mucosal neoplasia
  1. * Current use of aspirin, non-steroidal anti-inflammatory agents(NSAIDs),or chronic anticoagulants that cannot be discontinued prior to the procedure.
  2. * Inability to provide written informed consent
  3. * Significant thrombocytopenia or coagulopathy
  4. * Any significant co-morbid condition that would prevent the safe administration of conscious sedation

Contacts and Locations

Study Contact

April Higbee, BN
CONTACT
8168614700
April.Higbee@va.gov

Principal Investigator

Prateek Sharma, MD
PRINCIPAL_INVESTIGATOR
Kansas City VA Medical Center

Study Locations (Sites)

Kansas city VA Medical center
Kansas City, Missouri, 64128
United States

Collaborators and Investigators

Sponsor: Midwest Biomedical Research Foundation

  • Prateek Sharma, MD, PRINCIPAL_INVESTIGATOR, Kansas City VA Medical Center

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 Date2007-05-15
Study Completion Date2026-12-30

Study Record Updates

Study Start Date2007-05-15
Study Completion Date2026-12-30

Terms related to this study

Keywords Provided by Researchers

  • Barrett's Esophagus
  • Neoplasia
  • Endoscopic mucosal resection
  • High resolution endoscopy
  • Chromoendoscopy

Additional Relevant MeSH Terms

  • Barrett's Esophagus
  • Neoplasms
  • Gastroesophageal Reflux