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

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Colorado, Denver
Study ID
NCT02634645
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • Endoscopic eradication therapies (EET) — PROCEDURE
    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 — PROCEDURE
    The esophagus is surgically removed
  • Chemotherapy — DRUG
    Chemical substances are used to treat cancer
  • Radiation — RADIATION
    Cancer cells are destroyed by radiation therapy.

Study Details

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).

Key Dates

Start date
Jan 31, 2015
Status verified
Feb 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
5,000 participants (estimated)

Arms

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

Primary Outcome Measure

Overall improvement of patient outcomes in patients treated with endoscopic eradication therapy (EET). [ Time Frame: 5 years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
UCLA Medical CenterLos AngelesCalifornia90095
V. Raman Muthusamy, MD
310-825-1892
V. Raman Muthusamy, MD (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33612
Cynthia Harris, MD
813-745-8361
Cynthia Harris, MD (PRINCIPAL_INVESTIGATOR)
Jason Klapman, MD (SUB_INVESTIGATOR)
Northwestern Memorial HospitalChicagoIllinois60611
Srinadh Komanduri, MD
312-695-0484
Srinadh Komanduri, MD (PRINCIPAL_INVESTIGATOR)
Washington UniversitySt LouisMissouri63130
Dayna Early, MD

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