Randomised controlled trial of surveillance and no surveillance for patients with Barrett's oesophagus

ISRCTN	ISRCTN54190466
DOI	https://doi.org/10.1186/ISRCTN54190466
ClinicalTrials.gov number	NCT00987857
Secondary identifying numbers	HTA 05/12/01

Submission date: 27/12/2007
Registration date: 08/01/2008
Last edited: 01/07/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

http://www.cancerhelp.org.uk/trials/a-trial-looking-at-how-often-to-monitor-people-with-barretts-oesophagus

Contact information

Prof Hugh Barr
Scientific

Gloucestershire Royal Hospital
Great Western Road
Gloucester
GL1 3NN
United Kingdom

Email	hugh.barr@nhs.net

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Randomised controlled trial of surveillance and no surveillance for patients with Barrett's oesophagus: BOSS (Barrett's Oesophagus Surveillance Study)
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(s)	Submission pending as of 02/01/2008
Condition	Barrett's oesophagus
Intervention	Upper gastrointestinalendoscopy every 2 years for 10 years
Intervention type	Procedure/Surgery
Primary outcome measure	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 study start date	01/09/2009
Overall study end date	30/06/2022

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	2,500
Total final enrolment	3520
Participant inclusion criteria	Patients over 18 with endoscopic and histologically proven barrett's oesophagus greater than 1 cm
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

England
United Kingdom

Study participating centre

Gloucestershire Royal Hospital

Gloucester
GL1 3NN
United Kingdom

Sponsor information

Gloucestershire Royal NHS Foundation Trust (UK)
Hospital/treatment centre

Research and Development Support Unit
Great western Road
Gloucester
GL1 3NN
England
United Kingdom

Phone	+44 (0)8454 226679
Email	hugh.barr@glos.nhs.uk
"ROR"	https://ror.org/04mw34986

Funders

Funder type

Government

Health Technology Assessment Programme
Government organisation / National government

Alternative name(s): NIHR Health Technology Assessment Programme, HTA
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/09/2015		Yes	No

Editorial Notes

01/07/2022: The following changes were made to the trial record:
1. The contact email was updated.
2. The total final enrolment was added.
13/02/2020: ClinicalTrials.gov number added.
15/04/2016: Publication reference added.