Esophageal CancerNCT00987857
Endoscopy Every 2 Years or Only as Needed in Monitoring Patients With Barrett Esophagus
A study testing 2 yearly endoscopy, comparison of screening methods and diagnostic endoscopic procedure in people with Esophageal Cancer and Precancerous Condition, run by Gloucestershire Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Esophageal Cancer, Precancerous Condition
- What is being tested?
- 2 yearly endoscopy, comparison of screening methods and diagnostic endoscopic procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2009to May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Gloucestershire Royal Hospital
Gloucester, England, GL1 3NN
About this study
Official title: Barrett's Oesophagus Two Yearly Surveillance Versus Endoscopy at Need: a Randomised Controlled Trial to Estimate Effectiveness and Cost-effectiveness Study (BOSS)
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.
Read the 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).
- Conditions
- Esophageal Cancer, Precancerous Condition
- Being tested
- 2 yearly endoscopy, comparison of screening methods, diagnostic endoscopic procedure, endoscopic biopsy, endoscopic procedure
- Keywords
- esophageal cancer, adenocarcinoma of the esophagus, Barrett esophagus
- Medical subject headings
- Esophageal Neoplasms, Precancerous Conditions, Adenocarcinoma Of Esophagus, Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 yearly endoscopyProcedure or surgery
2 yearly endoscopy versus endoscopy at need
comparison of screening methodsProcedure or surgery
2 yearly endoscopy versus endoscopy at need
diagnostic endoscopic procedureProcedure or surgery
2 yearly endoscopy versus endoscopy at need
endoscopic biopsyProcedure or surgery
2 yearly endoscopy versus endoscopy at need
endoscopic procedureProcedure or surgery
2 yearly endoscopy versus endoscopy at need
quality-of-life assessmentProcedure or surgery
QOL aims to elicit any differences in QOL between 2 yearly endoscopy versus endoscopy at need
screening methodProcedure or surgery
All Barretts patients to be screened
| Study group | Role | What they receive |
|---|---|---|
| 2 yearly endoscopies | Active comparator | Two years endoscopies Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Frequency of endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2009 (estimated)
- Study startMar 2009
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gloucestershire Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clive Stokes, Gloucestershire Hospitals NHS Foundation Trust
- Investigators
- Hugh Barr, Principal investigator, Gloucestershire Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987857
- Sponsor's protocol ID
- NHS-GRH-HTA-05/12/01
- Other IDs
- CDR0000649890, ISRCTN54190466
- Status last verified
- Aug 2017
- First submitted
- 30 Sep 2009
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 40180292
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barrett's Oesophagus Two Yearly Surveillance Versus Endoscopy at Need: a Randomised Controlled Trial to Estimate Effectiveness and Cost-effectiveness Study (BOSS)
- ClinicalTrials.gov ID
- NCT00987857
- Acronym / sponsor ID
- NHS-GRH-HTA-05/12/01
- Conditions
- Esophageal Cancer, Precancerous Condition
- Keywords
- esophageal cancer, adenocarcinoma of the esophagus, Barrett esophagus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,400 participants (actual)
- Lead sponsor
- Gloucestershire Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 1 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 yearly endoscopies | Active comparator | 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 methodTwo years endoscopies |
| endoscopy at need | Experimental | 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 methodEndoscopy only when patient reports symptoms |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2 yearly endoscopy2 yearly endoscopy versus endoscopy at need | Procedure or surgery | 2 yearly endoscopies, endoscopy at need |
| comparison of screening methods2 yearly endoscopy versus endoscopy at need | Procedure or surgery | 2 yearly endoscopies, endoscopy at need |
| diagnostic endoscopic procedure2 yearly endoscopy versus endoscopy at need | Procedure or surgery | 2 yearly endoscopies, endoscopy at need |
| endoscopic biopsy2 yearly endoscopy versus endoscopy at need | Procedure or surgery | 2 yearly endoscopies, endoscopy at need |
| endoscopic procedure2 yearly endoscopy versus endoscopy at need | Procedure or surgery | 2 yearly endoscopies, endoscopy at need |
| quality-of-life assessmentQOL aims to elicit any differences in QOL between 2 yearly endoscopy versus endoscopy at need | Procedure or surgery | 2 yearly endoscopies, endoscopy at need |
| screening methodAll Barretts patients to be screened | Procedure or surgery | 2 yearly endoscopies, endoscopy at need |
Primary outcome
Overall survival
6 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Derived from this study: PubMed 40180292Old 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugh Barr principal investigator
Gloucestershire Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2 yearly endoscopy, comparison of screening methods and diagnostic endoscopic procedure in people with Esophageal Cancer and Precancerous Condition, run by Gloucestershire Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00987857, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.