Recurrent Barrett's esophagus-related neoplasia is uncommon after successful endoscopic eradication therapy over long-term follow-up.
Thomas Enke, Sridevi K Pokala, Colin Hensen...
https://pubmed.ncbi.nlm.nih.gov/41758692Actively Recruiting
Age: 18Years - 100Years
All Genders
Healthy Volunteers
ID02634645
A Multicenter Prospective Study Evaluating Outcomes of Endoscopic Eradication Therapy in Patients With Barrett's Esophagus Associated Neoplasia: The TREAT-BE Consortium
Led by University of Colorado, Denver · Updated on 2025-02-28
5000
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
N
Northwestern University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study focuses on patients with Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC), including those with Barrett's related neoplasia and esophageal cancer. It evaluates outcomes of endoscopic eradication therapies (EET) and other treatments in a prospective manner, aiming to improve patient care and understand long-term effects and risks associated with Barrett's esophagus and related cancers. Participants receive treatments based on their condition: patients with Barrett's related dysplasia or neoplasia undergo endoscopic eradication therapies such as mucosal resection, radiofrequency ablation, and cryotherapy. Those with invasive esophageal cancer receive treatments like surgery (esophagectomy), chemotherapy, radiation, or palliative care. The study collects detailed treatment information including advanced imaging, tissue sampling, and any complications related to procedures or surgeries. During the study, patients provide demographic and medical history data, complete questionnaires on gastroesophageal reflux disease (GERD) symptoms and quality of life, and undergo endoscopic and histopathological evaluations. Researchers track outcomes over five years, including treatment effectiveness, recurrence rates, adverse events, and healthcare utilization. This long-term monitoring aims to assess overall improvements and durability of therapies while documenting risk factors and imaging impacts.
CONDITIONS
Brief Title
TREAT-BE Study (Treatment With Resection and Endoscopic Ablation Techniques for Barrett's Esophagus)
Who Can Participate
Age: 18Years - 100Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Patients with Barrett's related neoplasia and dysplasia
- Patients with esophageal cancer
- Age 18 to 100 years
- Both male and female patients
You will not qualify if you...
- Patients with squamous cell carcinoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Initial evaluation period
Participants undergo endoscopic and histopathology evaluations to document Barrett's Esophagus and related neoplasia or invasive esophageal cancer.
1 to 2 visits depending on assessments
Treatment
Duration - Variable depending on treatment modality and patient condition
Participants receive treatment based on their condition, including endoscopic eradication therapies (EMR, RFA, cryotherapy) for Barrett's related neoplasia or surgery, chemotherapy, and radiation for invasive esophageal cancer.
Multiple visits as needed for treatment procedures
Long-term Monitoring
Duration - Up to 5 years
Participants are followed for up to 5 years to assess treatment effectiveness, recurrence rates, quality of life, and health-care utilization.
Regular follow-up visits over 5 years
Trial Site Locations
Total: 4 locations
1
UCLA Medical Center
Los Angeles, California, United States, 90095
Actively Recruiting
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
3
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
4
Washington University
St Louis, Missouri, United States, 63130
Actively Recruiting
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Research Team
S
Sachin Wani, MD
V
Violette C Simon, MS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Recurrence Is Rare Following Complete Eradication of Intestinal Metaplasia in Patients With Barrett's Esophagus and Peaks at 18 Months.
Sachin Wani, Samuel Han, Vladimir Kushnir...
https://pubmed.ncbi.nlm.nih.gov/31982610Anatomic location of Barrett's esophagus recurrence after endoscopic eradication therapy: development of a simplified surveillance biopsy strategy.
Mahmoud Omar, Adarsh M Thaker, Sachin Wani...
https://pubmed.ncbi.nlm.nih.gov/31004598