|Title:||Barretts Oesophagus Screening Trial|
|Principal research question:||Is the Cytosponge test an accurate and well-tolerated method to diagnose Barrett’s oesophagus in primary care?|
|Background:||Led by Dr Rebecca Fitzgerald and Dr Sunny Kadri of the MRC Cancer Cell Unit, this primary care study is looking into the accuracy and acceptability of a new non-endoscopic screening method (Cytosponge) for people at risk of developing Barrett's oesophagus, the main risk factor for oesophageal adenocarcinoma.
In Barrett's oesophagus , there are changes in the normal cells that line the food pipe (oesophagus or gullet). This is caused by acid coming back up the food pipe from the stomach (acid reflux). Over a long period of time, people with Barrett's oesophagus can develop ulcers or narrowing of the food pipe (oesophageal stricture). There is also a small increase in risk of oesophageal cancer. People with Barrett's oesophagus usually have an endoscopy every 2 years to check for these conditions.
There is no easy screening test available at the moment to pick up Barrett's oesophagus. Doctors are concerned that many people with Barrett's oesophagus may not be identified. People may be diagnosed with Barrett's oesophagus as a result of an endoscopy and biopsy (tissue sample). But this is quite an invasive test and doctors do not recommend that it is used routinely.
|Methodology description:||The Cytosponge is an ingestible gelatine capsule containing a compressed mesh attached to a string. After swallowing, the capsule dissolves in the proximal stomach to release the mesh, which is withdrawn after 5 minutes by pulling on the string. The cytological specimens are immediately placed into preservative fluid and transported to the laboratory for processing.|
|Sample group description:||Participants :
- Are between 50 and 70 years old
- Have taken medication for acid indigestion or heartburn for more than 3 months in the last 5 years as identified from the GP prescribing database.
- Only patients registered with specific participating GP practices are invited to take part.
|Outcome measure description:||1. Sensitivity and specificity of the test for detecting Barrett’s oesophagus with gastroscopy as gold standard;
2. Acceptability to participants (questionnaire using validated measures).
|Start date:||1st April 2007|
|End date:||31st March 2010|
|Contact person:||Dr Helen Morris|
|Contact Details:||Primary Care Research Unit
Institute of Public Health
University Forvie Site, Robinson Way
Telephone: (01223) 330592
Fax: 01223 762515
|Collaborative:||MRC Cancer Cell Unit, Cambridge: Dr Rebecca Fitzgerald (Project Leader), Dr Sudarshan Kadri, Pierre Lao-Sirieix, Irene Debiram, Madhumita Das
University of Cambridge: Professor Jon Emery, Dr Fiona Walter, Dr Helen Morris, Paul Pharoah
Addenbrooke's Hospital, Cambridge: Maria O’Donovan, Richard Hardwick
University of Bristol: Jane Blazeby
University of Melbourne: Alex Boussioutas
|Funding Organisation:||Medical Research Council|
|Funding Reference:||MRC-T Development Gap Fund Grant|
|Funding Organisation:||NIHR School for Primary Care Research|
|References and Publications|