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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03052335
Study type Interventional
Source Military University Hospital, Prague
Contact Stepan Suchanek, MD., Ph.D.
Phone 973208367
Email stepan.suchanek@uvn.cz
Status Recruiting
Phase N/A
Start date March 1, 2017
Completion date December 31, 2019

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