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

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Esophageal Cancer; Barrett's Esophagus

Treatments: Drug: Chemotherapy; Procedure: Esophagectomy; Procedure: Endoscopic eradication therapies (EET); Radiation: Radiation

Study type: Observational

Funder types: Other

Identifiers

NCT02634645

14-2371

Details and patient eligibility

About

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).

Full 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 .

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Patients with squamous cell carcinoma

Trial design

5,000 participants in 2 patient groups

Patients with Barrett's Esophagus

Description:

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).

Treatment:

Procedure: Endoscopic eradication therapies (EET)

Patients with invasive esophageal cancer

Description:

Patients with invasive esophageal cancer who will be treated with surgery (esophagectomy), chemotherapy, radiation, and palliative treatment modalities.

Treatment:

Radiation: Radiation

Drug: Chemotherapy

Procedure: Esophagectomy