Colon Cancer Clinical Trial
Official title:
The Comparison of the Efficiency of Colon Capsule Endoscopy and Optical Colonoscopy in Patients With Positive Immunochemical Fecal Occult Blood Test
Main objective is to improve colorectal cancer (CRC) screening programme in the Czech Republic and decrease the disease incidence and mortality. The secondary aim is to verify the effectiveness of incorporation of the new minimally invasive device in the prevention programme.
Multicentre, multidisciplinary (3 gastroenterology units; biostatistics department;
cooperation with general practitioners), prospective study is focused on examination of
individuals with average colorectal cancer (CRC) risk (asymptomatic, age 50-75 years).
In years 2017 - 2019, there will be 230 persons with positive semi-quantitative
immunochemical fecal occult blood tests (FIT; QuikRead, Orion Diagnostica Oy, Finland) with
cut-off level 75 ng/ml involved. Every person will be examined by second generation colon
capsule endoscopy (CCE2) and optical colonoscopy afterwards.
Main objective is to show that the negative predictive value (NPV) of the CCE2 applied in
patients with positive FIT results is sufficient to include this method in the National CRC
screening as filter test with aim to reduce the necessity of subsequent optical colonoscopy.
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