TREAT-BE Study (Treatment With Resection and Endoscopic Ablation Techniques for Barrett's Esophagus)
A Multicenter Prospective Study Evaluating Outcomes of Endoscopic Eradication Therapy in Patients With Barrett's Esophagus Associated Neoplasia: The TREAT-BE (Treatment With Resection and Endoscopic Ablation Techniques for Barrett's Esophagus) Consortium
1 other identifier
observational
5,000
1 country
4
Brief Summary
A prospective outcomes study in patients with and esophageal cancer (EAC) and Barrett's esophagus (BE) associated neoplasia being evaluated for endoscopic eradication therapy (EET).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2015
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 8, 2015
CompletedFirst Posted
Study publicly available on registry
December 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
February 28, 2025
February 1, 2025
12 years
June 8, 2015
February 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Overall improvement of patient outcomes in patients treated with endoscopic eradication therapy (EET).
A systematic, prospective collection of data from a large cohort of patients with BE and EAC undergoing EET will provide useful data in effort to improve overall patient outcomes.
5 years
Secondary Outcomes (14)
Long-term effectiveness or durability of EET in BE related neoplasia.
5 years
Quality of life (QOL) in patients undergoing endoscopic eradication therapies for Barrett's associated neoplasia
5 years
Recurrence rate of neoplasia
5 years
Recurrence rate of intestinal metaplasia
5 years
Recurrence rate based on baseline dysplasia, Barrett's length, and treatment modality
5 years
- +9 more secondary outcomes
Study Arms (2)
Patients with Barrett's Esophagus
Patients with non-dysplastic Barrett's esophagus, patients with Barrett's related dysplasia which includes low-grade dysplasia, high-grade dysplasia and intramucosal cancer who will be evaluated and treated with endoscopic eradication therapies (EET).
Patients with invasive esophageal cancer
Patients with invasive esophageal cancer who will be treated with surgery (esophagectomy), chemotherapy, radiation, and palliative treatment modalities.
Interventions
Endoscopic eradication therapies (EET) includes endoscopic mucosal resection (EMR), which describes the process by which the area most likely to harbor highest grade of dysplasia/neoplasia is removed; radiofrequency ablation (RFA), which describes the process by which Barrett's segments are removed via burning/ablation; and cryotherapy.
Chemical substances are used to treat cancer
Cancer cells are destroyed by radiation therapy.
Eligibility Criteria
Formation of a multi-site prospective database of patients with BE associated neoplasia referred for consideration for EET and EAC. Women and minorities will be included as they are found to have BE, BE related dysplasia, and EAC. It is well recognized that the majority of patients diagnosed with BE are white males. However, we will actively seek to include all women and minorities with a diagnosis of BE associated neoplasia for the study.
You may qualify if:
- Patients with Barrett's related neoplasia and dysplasia. Patients with esophageal cancer
You may not qualify if:
- Patients with squamous cell carcinoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- Northwestern University Feinberg School of Medicinecollaborator
- University of California, Los Angelescollaborator
- H. Lee Moffitt Cancer Center and Research Institutecollaborator
- California Pacific Medical Centercollaborator
Study Sites (4)
UCLA Medical Center
Los Angeles, California, 90095, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Washington University
St Louis, Missouri, 63130, United States
Related Publications (2)
Wani S, Han S, Kushnir V, Early D, Mullady D, Hammad H, Brauer B, Thaker A, Simon V, Ezekwe E, Hollander T, Wood M, Rastogi A, Edmundowicz S, Muthusamy VR, Komanduri S. Recurrence Is Rare Following Complete Eradication of Intestinal Metaplasia in Patients With Barrett's Esophagus and Peaks at 18 Months. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2609-2617.e2. doi: 10.1016/j.cgh.2020.01.019. Epub 2020 Jan 23.
PMID: 31982610DERIVEDOmar M, Thaker AM, Wani S, Simon V, Ezekwe E, Boniface M, Edmundowicz S, Obuch J, Cinnor B, Brauer BC, Wood M, Early DS, Lang GD, Mullady D, Hollander T, Kushnir V, Komanduri S, Muthusamy VR. Anatomic location of Barrett's esophagus recurrence after endoscopic eradication therapy: development of a simplified surveillance biopsy strategy. Gastrointest Endosc. 2019 Sep;90(3):395-403. doi: 10.1016/j.gie.2019.04.216. Epub 2019 Apr 17.
PMID: 31004598DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sachin Wani, MD
University of Colorado, Denver
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2015
First Posted
December 18, 2015
Study Start
January 1, 2015
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
February 28, 2025
Record last verified: 2025-02