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

NCT00987857 | Unknown DMC

• 3 other identifiers: NHS-GRH-HTA-05/12/01CDR0000649890ISRCTN54190466
• Study Type: interventional
• Target: 3,400
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

esophageal cancer; adenocarcinoma of the esophagus; Barrett esophagus

Outcome Measures

Primary Outcomes (1)

• Overall survival

Secondary Outcomes (6)

• 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

Study Arms (2)

2 yearly endoscopies

ACTIVE COMPARATOR

Two years endoscopies

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

endoscopy at need

EXPERIMENTAL

Endoscopy only when patient reports symptoms

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

Interventions

2 yearly endoscopy PROCEDURE

2 yearly endoscopy versus endoscopy at need

2 yearly endoscopies; endoscopy at need

comparison of screening methods PROCEDURE

2 yearly endoscopy versus endoscopy at need

2 yearly endoscopies; endoscopy at need

diagnostic endoscopic procedure PROCEDURE

2 yearly endoscopy versus endoscopy at need

2 yearly endoscopies; endoscopy at need

endoscopic biopsy PROCEDURE

2 yearly endoscopy versus endoscopy at need

2 yearly endoscopies; endoscopy at need

endoscopic procedure PROCEDURE

2 yearly endoscopy versus endoscopy at need

2 yearly endoscopies; endoscopy at need

quality-of-life assessment PROCEDURE

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

2 yearly endoscopies; endoscopy at need

screening method PROCEDURE

All Barretts patients to be screened

2 yearly endoscopies; endoscopy at need

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gloucestershire Hospitals NHS Foundation Trust: lead

Study Sites (1)

Gloucestershire Royal Hospital

Gloucester, England, GL1 3NN, United Kingdom

Location

Related Publications (1)

• Old O, Jankowski J, Attwood S, Stokes C, Kendall C, Rasdell C, Zimmermann A, Massa MS, Love S, Sanders S, Deidda M, Briggs A, Hapeshi J, Foy C, Moayyedi P, Barr H; BOSS Trial Team. Barrett's Oesophagus Surveillance Versus Endoscopy at Need Study (BOSS): A Randomized Controlled Trial. Gastroenterology. 2025 Nov;169(6):1233-1243.e8. doi: 10.1053/j.gastro.2025.03.021. Epub 2025 Apr 1.

  PMID: 40180292 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms; Precancerous Conditions; Adenocarcinoma Of Esophagus; Barrett Esophagus

Interventions

Endoscopic Mucosal Resection; Endoscopy; High-Throughput Screening Assays

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Hugh Barr

  Gloucestershire Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Hugh Barr

Study Record Dates

• First Submitted: September 30, 2009
• First Posted: October 1, 2009
• Study Start: March 1, 2009
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: August 22, 2017

Record last verified: 2017-08

Locations

GB (1)