Condition category
Digestive System
Date applied
27/12/2007
Date assigned
08/01/2008
Last edited
15/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Prof Hugh Barr

ORCID ID

Contact details

Gloucestershire Royal Hospital
Great Western Road
Gloucester
GL1 3NN
United Kingdom
-
hugh.barr@glos.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 05/12/01

Study information

Scientific title

Randomised controlled trial of surveillance and no surveillance for patients with Barrett's oesophagus: BOSS (Barrett's Oesophagus Surveillance Study)

Acronym

BOSS

Study hypothesis

Comparison of endoscopic surveillance verus no endoscopic surveillance for the prevention of early mortality and the development of oesophageal adenocarcinoma.

Ethics approval

Submission pending as of 02/01/2008

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Barrett's oesophagus

Intervention

Upper gastrointestinalendoscopy every 2 years for 10 years

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. All causes mortality
2. Death from adenocarcinoma
3. Development of treatable adenocarcinoma
Duration of follow-up: 10 years

Secondary outcome measures

1. Quality of life: Reflux Questionnaire and EQ50 Quality of Life Questionnaire at yearly intervals by post
2. Cost effectiveness of endoscopy

Overall trial start date

01/09/2009

Overall trial end date

30/06/2022

Reason abandoned

Eligibility

Participant inclusion criteria

Patients over 18 with endoscopic and histologically proven barrett's oesophagus greater than 1 cm

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2,500

Participant exclusion criteria

1. Unable to give consent
2. Unable to tolerate upper gastrointestinal endoscopy

Recruitment start date

01/09/2009

Recruitment end date

30/06/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Gloucestershire Royal Hospital
Gloucester
GL1 3NN
United Kingdom

Sponsor information

Organisation

Gloucestershire Royal NHS Foundation Trust (UK)

Sponsor details

Research and Development Support Unit
Great western Road
Gloucester
GL1 3NN
United Kingdom
+44 (0)8454 226679
hugh.barr@glos.nhs.uk

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25767103

Publication citations

Additional files

Editorial Notes

15/04/2016: Publication reference added.