| Source of record | UK Trials |
| ISRCTN | ISRCTN54190466 |
| Date ISRCTN assigned | 08/01/2008 |
| Local reference number(s) | HTA 05/12/01 |
| Public title | Randomised controlled trial of surveillance and no surveillance for patients with Barrett's oesophagus: BOSS (Barrett's Oesophagus Surveillance Study) |
| Scientific title |
|
| Acronym | BOSS |
| Disease/condition/study domain | Barrett's oesophagus |
| Study hypothesis | Comparison of endoscopic surveillance verus no endoscopic surveillance for the prevention of early mortality and the development of oesophageal adenocarcinoma. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Submission pending as of 2nd January 2008 |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Patients over 18 with endoscopic and histologically proven barrett's oesophagus greater than 1 cm |
| Participants - exclusion criteria | 1. Unable to give consent
2. Unable to tolerate upper gastrointestinal endoscopy |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Anticipated start date | 01/09/2008 |
| Anticipated end date | 01/09/2021 |
| Status of trial | Ongoing |
| Target number of participants | 2,500 |
| Interventions | Upper gastrointestinalendoscopy every 2 years for 10 years |
| Primary outcome measure(s) | 1. All causes mortality
2. Death from adenocarcinoma
3. Development of treatable adenocarcinoma
Duration of follow-up: 10 years |
| Secondary outcome measure(s) | 1. Quality of life: Reflux Questionnaire and EQ50 Quality of Life Questionnaire at yearly intervals by post
2. Cost effectiveness of endoscopy |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Sponsor name | Gloucestershire Royal NHS Foundation Trust (UK) |
| Sponsor details | Research and Development Support Unit
Great western Road
Gloucester
United Kingdom
GL1 3NN |
| Sponsor telephone | +44 (0)8454 226679 |
| Sponsor fax | +44 (0)8454 226813 |
| Sponsor email | hugh.barr@glos.nhs.uk |
| Contact name | Prof Hugh Barr |
| Contact details | Gloucestershire Royal Hospital
Great Western Road
Gloucester
United Kingdom
GL1 3NN |
| Contact email | hugh.barr@glos.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN54190466 |
| Date last extracted from ISRCTN register | 17/04/2008 |
