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Point of Care Faecal Immunochemical Testing for Colorectal Cancer

ABSTRACT: Blood that can be detected in stool via faecal immunochemical testing is a recognised risk factor for the presence of colorectal cancer. There are a number of point of care faecal immunochemical testing devices available. This study is to trial one of these machines into the clinical setting to see if the results are safe and accurate as a ‘rule out’ test for colorectal cancer. We will be investigating patients that present with symptoms or anaemia to their GP and are referred on the two-week rule pathway to our hospital. It has also been advocated that digital rectal examination (which is part of the routine assessment for a patient presenting to colorectal clinic) provides an opportunity to use a small sample of stool from a gloved finger to perform faecal immunochemical testing. We will be comparing a patient provided sample with a DRE sample on a standard laboratory-based machine.

DISEASE(S): Colorectal Cancer,Colorectal Neoplasms

PROVIDER: 2340309 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description: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

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Point of Care Faecal Immunochemical Testing for Colorectal Cancer

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