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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Clive Stokes, Gloucestershire Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00987857
First received: September 30, 2009
Last updated: August 17, 2017
Last verified: August 2017
  Purpose

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.


Condition Intervention
Esophageal Cancer Precancerous Condition Procedure: 2 yearly endoscopy Procedure: comparison of screening methods Procedure: diagnostic endoscopic procedure Procedure: endoscopic biopsy Procedure: endoscopic procedure Procedure: quality-of-life assessment Procedure: screening method

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Barrett's Oesophagus Two Yearly Surveillance Versus Endoscopy at Need: a Randomised Controlled Trial to Estimate Effectiveness and Cost-effectiveness Study (BOSS)

Resource links provided by NLM:


Further study details as provided by Clive Stokes, Gloucestershire Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Overall survival

Secondary Outcome Measures:
  • Cost-effectiveness
  • Incidence of esophageal cancer, gastric or esophageal cancer, or all cancers
  • Time to diagnosis of esophageal adenocarcinoma
  • Stage of esophageal adenocarcinoma at diagnosis using TNM staging
  • Morbidity and mortality related to endoscopy, esophageal surgery, and other endoscopy-related interventions
  • Frequency of endoscopy

Enrollment: 3400
Study Start Date: March 2009
Estimated Study Completion Date: May 2022
Estimated Primary Completion Date: May 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2 yearly endoscopies
Two years endoscopies
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
Experimental: endoscopy at need
Endoscopy only when patient reports symptoms
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

Detailed Description:

OBJECTIVES:

Primary

  • To establish whether endoscopic surveillance every 2 years or endoscopy at need only is superior in terms of overall survival and, if neither is superior, whether endoscopy at need only is non-inferior to surveillance every 2 years in patients with Barrett esophagus.

Secondary

  • To estimate the cost-effectiveness of endoscopic surveillance every 2 years as compared to endoscopy at need only.
  • To establish whether there is a significant difference between endoscopic surveillance every 2 years or endoscopy at need only in terms of the incidence of esophageal cancer, gastric or esophageal cancer, or all cancers.
  • To establish whether there is a significant difference between endoscopic surveillance every 2 years or endoscopy at need only in terms of the time to diagnosis of esophageal adenocarcinoma.
  • To establish whether there is a significant difference between endoscopic surveillance every 2 years or endoscopy at need only in terms of the stage of esophageal adenocarcinoma at diagnosis using TNM staging.
  • To establish whether there is a significant difference between endoscopic surveillance every 2 years or endoscopy at need only in terms of morbidity and mortality related to endoscopy, esophageal surgery, and other endoscopy-related interventions (e.g., ablation).
  • To establish whether there is a significant difference between endoscopic surveillance every 2 years or endoscopy at need only in terms of the frequency of endoscopy.

OUTLINE: This is a multicenter study. Patients are stratified according to age at diagnosis (< 65 years vs ≥ 65 years), length of Barrett metaplasia segment including tongues (< 2 cm vs ≥ 2 cm and ≤ 3 cm vs > 3 cm and ≤ 8 cm vs > 8 cm), and newly diagnosed disease (defined as the date of endoscopy confirming Barrett metaplasia was within the past 4 months) (yes vs no). Patients are randomized to 1 of 2 intervention arms.

  • Arm I: Patients undergo surveillance endoscopy with quadrantic biopsies taken every 2 cm. Patients undergo endoscopy every 2 years for a total of 6 endoscopies over 10 years.
  • Arm II: Patients undergo endoscopy as needed over 10 years. All patients may undergo urgent endoscopy if they develop dysphagia, unexplained weight loss of > 7 lb, iron-deficiency anemia, recurrent vomiting, or worsening upper gastrointestinal symptoms.

All patients complete a questionnaire that includes a quality-of-life measure and questions about medication at baseline, every 2 years, and following key events (e.g., diagnosis of any cancer or high-grade dysplasia).

  Eligibility

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed circumferential Barrett metaplasia meeting 1 of the following criteria:

    • At least 1 cm from the gastro-esophageal junction
    • At least a 2 cm non-circumferential tongue of Barrett metaplasia
  • Undergone endoscopy within the last 2 years to confirm Barrett metaplasia and exclude high-grade dysplasia and carcinoma
  • No known high-grade dysplasia or carcinoma

PATIENT CHARACTERISTICS:

  • Resident of the United Kingdom
  • Informed of the risk of Barrett esophagus developing into esophageal cancer, either at the visit when the invitation letter is issued or on a documented previous occasion
  • Able to undergo endoscopy
  • No medical conditions that would make endoscopy difficult or hazardous

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00987857

Locations
United Kingdom
Gloucestershire Royal Hospital
Gloucester, England, United Kingdom, GL1 3NN
Sponsors and Collaborators
Gloucestershire Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Hugh Barr Gloucestershire Hospitals NHS Foundation Trust
  More Information

Responsible Party: Clive Stokes, Professor Hugh Barr, Gloucestershire Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00987857     History of Changes
Other Study ID Numbers: NHS-GRH-HTA-05/12/01
CDR0000649890 ( Registry Identifier: PDQ (Physician Data Query) )
ISRCTN54190466
Study First Received: September 30, 2009
Last Updated: August 17, 2017

Keywords provided by Clive Stokes, Gloucestershire Hospitals NHS Foundation Trust:
esophageal cancer
adenocarcinoma of the esophagus
Barrett esophagus

Additional relevant MeSH terms:
Esophageal Neoplasms
Barrett Esophagus
Precancerous Conditions
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Abnormalities

ClinicalTrials.gov processed this record on September 21, 2017