Extract

Background and study aims Most bowel cancers develop from adenomas, a type of small growth that grows on the bowel wall. Removing adenomas can help to prevent the development of cancer. The NHS now offers screening for bowel cancer to all men and women aged between 60 and 69 years and from 2010, the age range will be extended to 74 years. The screening test, called FOBT, looks for traces of blood in the stool. People who have a positive FOBT are offered colonoscopy, an examination in which an endoscope is used to examine the lining of the bowel for cancers and polyps. Those who have large or multiple adenomas found at colonoscopy are known to have an increased risk of developing more adenomas and possibly bowel cancer. Therefore they are currently offered surveillance colonoscopy at 3 year intervals. There are a number of problems with this approach. Colonoscopy is a costly procedure requiring a skilled doctor, and it carries a small risk of serious complications. It can miss lesions - indeed most advanced lesions (large adenomas or cancers) found at follow-up examinations were present but missed at the previous colonoscopy. Surveillance colonoscopy is also wasteful of resources because significant lesions are found in only about 3% of examinations, so 97% of surveillance colonoscopies will find either nothing or only small harmless adenomas. This is reassuring to the patient but offers no real benefit. Because more adenomas are now being found as a result of the NHS Bowel Cancer Screening Programme (BCSP), the number of surveillance colonoscopies is increasing and threatens to overwhelm available resources. A more cost-effective way of protecting people with higher-risk adenomas is required. We propose that a new type of stool test (faecal immunological test, FIT) could offer effective protection for this higher-risk group at a fraction of the cost. Only patients who had a positive FIT result would need to be offered colonoscopy. This study is designed to estimate the benefit of this approach. Who can participate? People who have taken part in the Bowel Cancer Screening Programme (BCSP) and have been diagnosed with large or multiple adenomas What does the study involve? Participants are offered the FIT at 1, 2 and 3 years. The test is very simple, requiring participants to collect a tiny amount of stool on a probe and return to the laboratory (easier than the FOBT which requires 6 stool samples). Participants who have a positive FIT result are offered a colonoscopy immediately and their next colonoscopy will be three years later. Those who do not test positive to any of the three annual FITs have their colonoscopy at 3 years in the usual way. We compare the total number of bowel lesions found in people who test positive at the 1st, 2nd or 3rd FITs with the number of lesions found at 3-year colonoscopy in those who had a negative FIT result. If most important lesions are found in the group who have positive FIT results, this would suggests that this new approach could provide effective protection and ultimately mean that colonoscopy could be used only in cases with a positive FIT result. What are the possible benefits and risks of participating? Participants who have a positive FIT results at Years 1 or 2 will be offered a colonoscopy early and some of them will have no adenomas detected, so it will not benefit them, but some participants will have important lesions found that would otherwise not be detected until 3 years and therefore will derive benefit. The FIT test will be offered in addition to the 3-year colonoscopy which is the current procedure and we will not be replacing their colonoscopy, so the risk of missing lesions is not increased. Where is the study run from? Imperial College London (UK) When is the study starting and how long is it expected to run for? January 2011 to December 2015 Who is funding the study? NIHR Health Technology Assessment Programme - HTA (UK) Who is the main contact? Prof Wendy S Atkin [email protected]

Inclusion criteria

• bowel cancer

Links

• isrctn
• ictrp