Prospective clinical validation of a novel multitarget FIT in the Dutch CRC screening program (mtFIT study)
Colorectal cancer screening with the use of a fecal immunochemical test (FIT) has been successfully implemented in several countries, including the Netherlands. However, FIT (which detects hemoglobin) has limited sensitivity as it misses 15-25% of the cancers and 70% of the high-risk precursor lesions (i.e. advanced adenomas). Therefore, an unmet medical need exists to improve the sensitivity, especially for the high-risk precursor lesions without losing specificity. The consortium has shown that this is feasible with a test (multitarget FIT; mtFIT) that detects three proteins in stool (i.e. SERPINF2 and calprotectin, in addition to hemoglobin), which they retrospectively validated in a series of 1284 colonoscopy controlled participants.
The present project will clinically validate mtFIT in a prospective study conducted within the Dutch CRC screening program. Moreover, a biobank of stool samples and curated clinical data will be created to support further development of the mtFIT into a product ready for clinical implementation. This project is a partnership between NKI-AVL and the spin-off company CRCbioscreen. A preliminary disease modelling analysis revealed that applying this biomarker test for screening could result in a decrease of 16% in colorectal cancer incidence and 11% of CRC deaths, when compared to FIT only. Upon a positive outcome of the prospective clinical validation study, will further develop mtFIT to a CE commercial marked product.
This project has three workpackages aimed at the preparation and execution of the prospective clinical validation study and consolidation of the samples and data collected, as a resource for future research and development towards implementation.
At the end of this project, the consortium will have an assessment of performance of the new assay compared to the current standard of care, the FIT.