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Endoscopy Every 2 Years or Only as Needed in Monitoring Patients With Barrett Esophagus

NCT00987857 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3400

Last updated 2017-08-22

No results posted yet for this study

Summary

RATIONALE: Screening tests may help doctors find cancer cells early and plan better treatment. It is not yet known whether endoscopy every 2 years is more effective than endoscopy only as needed in finding esophageal cancer in patients with Barrett esophagus.

PURPOSE: This randomized phase III trial is studying endoscopy every 2 years to see how well it works compared with endoscopy only as needed in monitoring patients with Barrett esophagus.

Conditions

  • Esophageal Cancer
  • Precancerous Condition

Interventions

PROCEDURE

2 yearly endoscopy

2 yearly endoscopy versus endoscopy at need

PROCEDURE

comparison of screening methods

2 yearly endoscopy versus endoscopy at need

PROCEDURE

diagnostic endoscopic procedure

2 yearly endoscopy versus endoscopy at need

PROCEDURE

endoscopic biopsy

2 yearly endoscopy versus endoscopy at need

PROCEDURE

endoscopic procedure

2 yearly endoscopy versus endoscopy at need

PROCEDURE

quality-of-life assessment

QOL aims to elicit any differences in QOL between 2 yearly endoscopy versus endoscopy at need

PROCEDURE

screening method

All Barretts patients to be screened

Sponsors & Collaborators

  • Gloucestershire Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Hugh Barr · Gloucestershire Hospitals NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2022-05-31
Completion
2022-05-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00987857 on ClinicalTrials.gov