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Patients with Barrett's Esophagus for Barrett's Esophagus

N/A

Recruiting

Led By Sachin Wani, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

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).

Eligible Conditions

Barrett's Esophagus
Esophageal Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall improvement of patient outcomes in patients treated with endoscopic eradication therapy (EET).

Secondary study objectives

Adverse event rates associated with EET for BE associated neoplasia and EAC.

Neoplasms

Impact of endoscopic and radiologic imaging modalities.

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Patients with invasive esophageal cancerExperimental Treatment3 Interventions

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

Group II: Patients with Barrett's EsophagusExperimental Treatment1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Esophagectomy

2016

Completed Phase 3

~4130

Radiation

2003

Completed Phase 2

~780