TREAT-BE Study (Treatment With Resection and Endoscopic Ablation Techniques for Barrett's Esophagus)

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02634645
• Other study ID #: 14-2371
• Status: Recruiting
• Start date: January 2015
• Est. completion date: January 2027

Study information

• Verified date: June 2023
• Source: University of Colorado, Denver
• Contact: Sachin Wani, MD
• Phone: 720-848-2786
• Email: sachin.wani[@]ucdenver.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

Patients will be enrolled in this study at the participating centers when evaluated in gastro-intestinal (GI) clinics and endoscopy suites. Initial evaluation of patients will include collection of data on demographics, assessment of risk factors such as smoking, metabolic syndrome, family history and detailed medication history, and past surgical history. All patients will be complete questionnaires regarding Gastroesophageal Reflux Disease (GERD) symptoms, GERD related quality of life (QOL) and overall health related QOL. Details of all previous endoscopic and surgical evaluation along with histopathology data will be documented. Patients undergoing endoscopic evaluation at the participating centers will have their endoscopic and histopathology results documented. This will include data collection regarding use of advanced imaging techniques, details regarding tissue acquisition, EET and adverse events. Patients undergoing esophagectomy will have surgical details documented along with complications related to surgery. Similarly, details regarding chemoradiation treatments will be documented .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients with Barrett's related neoplasia and dysplasia. Patients with esophageal cancer

Exclusion Criteria:

• Patients with squamous cell carcinoma

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus
• Esophageal Cancer

Intervention

Procedure:
• Endoscopic eradication therapies (EET)
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.
• Esophagectomy
The esophagus is surgically removed

Drug:
• Chemotherapy
Chemical substances are used to treat cancer

Radiation:
• Radiation
Cancer cells are destroyed by radiation therapy.

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	UCLA Medical Center	Los Angeles	California
United States	Washington University	Saint Louis	Missouri
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (5)

Lead Sponsor	Collaborator
University of Colorado, Denver	California Pacific Medical Center, H. Lee Moffitt Cancer Center and Research Institute, Northwestern University Feinberg School of Medicine, University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Long-term effectiveness or durability of EET in BE related neoplasia.	To report on long-term effectiveness or durability of EET in BE related neoplasia.	5 years
Secondary	Quality of life (QOL) in patients undergoing endoscopic eradication therapies for Barrett's associated neoplasia	To assess quality of life (QOL) using the Promise GERD HRQL (Health Related Quality of Life) questionnaire in patients undergoing endoscopic eradication therapies for Barrett's associated neoplasia	5 years
Secondary	Recurrence rate of neoplasia	To report on the recurrence rate of neoplasia (defined as number of patients with established eradicated neoplasia post-EET who are found to have recurrent intestinal metaplasia on subsequent surveillance biopsies)	5 years
Secondary	Recurrence rate of intestinal metaplasia	To report on the recurrence rate intestinal metaplasia (defined as number of patients with established eradicated intestinal metaplasia and/or neoplasia post-EET who are found to have recurrent intestinal metaplasia on subsequent surveillance biopsies).	5 years
Secondary	Recurrence rate based on baseline dysplasia, Barrett's length, and treatment modality	Percentage of patients of different baseline Barrett's treatment modalities (EMR vs. RFA vs. cryotherapy) whose Barrett's is persistent despite treatment and/or recurs post-eradication. Percentage of patients of different baseline Barrett's lengths whose Barrett's is persistent despite treatment and/or recurs post-eradication. Percentage of patients of different baseline Barrett's histologies (i.e. high grade dysplasia/intramucosal cancer vs. low grade dysplasia) whose Barrett's is persistent despite treatment and/or recurs post-eradication.	5 years
Secondary	Persistence rate based on baseline dysplasia, Barrett's length, and treatment modality	Percentage of patients of different baseline Barrett's treatment modalities (EMR vs. RFA vs. cryotherapy) whose Barrett's is persistent despite treatment and/or recurs post-eradication. Percentage of patients of different baseline Barrett's lengths whose Barrett's is persistent despite treatment and/or recurs post-eradication. Percentage of patients of different baseline Barrett's histologies (i.e. high grade dysplasia/intramucosal cancer vs. low grade dysplasia) whose Barrett's is persistent despite treatment and/or recurs post-eradication.	5 years
Secondary	Adverse event rates associated with EET for BE associated neoplasia and EAC.	To determine adverse event rates associated with EET for BE associated neoplasia and EAC.	5 years
Secondary	Determine health-care utilization including endoscopic surveillance practices and outcomes in BE patients with and without neoplasia	Number of BE patients (both with and without neoplasia) in the general population who receive various endoscopic interventions (including RFA, cryotherapy, EMR, endoscopic surveillance)	5 years
Secondary	Magnitude of risk factors for BE.	The number of BE patients who fall into specific age cohorts; the number of BE patients who are male/female; the number of BE patients who fall into specific BMI cohorts; the number of BE patients who have used tobacco and/or currently use tobacco; the number of BE patients who have GERD symptoms; the number of BE patients who have metabolic syndrome; the number of BE patients who take aspirin, NSAIDS, anti-hyperglycemic medications, and/or statins.	5 years
Secondary	Magnitude of risk factors for BE related neoplasia.	The number of BE related neoplasia patients who fall into specific age cohorts; the number of BE related neoplasia patients who are male/female; the number of BE related neoplasia patients who fall into specific BMI cohorts; the number of BE related neoplasia patients who have used tobacco and/or currently use tobacco; the number of BE related neoplasia patients who have GERD symptoms; the number of BE related neoplasia patients who have metabolic syndrome; the number of BE related neoplasia patients who take aspirin, NSAIDS, anti-hyperglycemic medications, and/or statins.	5 years
Secondary	Magnitude of risk factors for EAC.	The number of EAC patients who fall into specific age cohorts; the number of EAC patients who are male/female; the number of EAC patients who fall into specific BMI cohorts; the number of EAC patients who have used tobacco and/or currently use tobacco; the number of EAC patients who have GERD symptoms; the number of EAC patients who have metabolic syndrome; the number of EAC patients who take aspirin, NSAIDS, anti-hyperglycemic medications, and/or statins.	5 years
Secondary	Impact of endoscopic and radiologic imaging modalities.	Number of patients whose treatment plan changes due to endoscopic ultrasound and/or Computed Tomography-Positron Emission Tomography (CT-PET) findings	5 years
Secondary	Median time to recurrence of intestinal metaplasia	To report on the median time to recurrence (measured median amount of months between complete eradication and recurrence of intestinal metaplasia).	5 years
Secondary	Median time to recurrence of neoplasia	To report on the median time to recurrence (measured median amount of months between complete eradication and recurrence of neoplasia).	5 years