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A comparison of the accuracy of two bowel cancer test kits in healthy people.

ABSTRACT: Interventions: The study is an open study designed to determine the clinical specificity of the bowel cancer screening tests QuickVue(R) faecal immunochemical test (FIT) and to compare this to Hemoccult II(R) Sensa(R). A new immunochemical, faecal occult blood test (FOBT) QuickVue(R)FIT has recently been developed, that incorporates features that may result in improved population participation. These features relate to sampling process itself where a specimen is taken by inserting into the stool a small grooved probe instead of the more traditional spatula sampling; therefore the QuickVue(R) FIT device uses a stool sampling procedure where a small probe is inserted into the stool surface at multiple points and then transferred to a plastic container containing a stabilization solution which is then sealed. The test is then activated and a stable test result is generated which is concealed from the participant. The Hemoccult II(R) Sensa(R) device is a guaiac (chemical) test, which employs a direct stick-based faecal sampling method to collect a sample from a stool captured by defaecating onto a stool collection sheet held above toilet bowel water. The faecal sample is then smeared onto a collection card by the patient using a small wooden spatula, allowed to dry and sent to the developing laboratory using postal system approved packaging. Therefore one significant difference between these devices is that the Hemoccult II(R) Sensa(R) uses a stick-based stool sampling method while the QuickVue(R) FIT uses a probe sampling method. While there are other inherent differences between the sampling methodologies used in the QuickVue(R) FIT and the Hemoccult II(R) Sensa(R) test devices, a study based on a direct, per-stool comparison is practical. To complete bo Primary outcome(s): The primary aim of this study is to compare the clinical specificity (proportion of positive tests in a population known not to have the condition under test) of the faecal immunochemical test (FIT) QuickVueRegistered Trade Mark (R) relative to an approved chemical device Hemoccult II(R) Sensa(R) The device end point and result for each patient will be defined as per the device manufacture?s instructions. In the case of the Hemoccult II(R) Sensa(R) device, a positive result recorded for one or more of the six individual samples, corresponding to three separate bowel movements, will yield a positive result for that patient. In the case of the QuickVue(R) FIT test, the positivity or negativity for that patient will be interpreted in similar fashion.[Specificity is assessed at completion of both tests] Study Design: Purpose: Screening;Duration: Cross-sectional;Selection: Defined population;Timing: Prospective

DISEASE(S): Bowel Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)

PROVIDER: 2455847 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description: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.

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A comparison of the accuracy of two bowel cancer test kits in healthy people.

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