December 14, 2022
The antibody-based multitargetFIT (mtFIT) for colorectal cancer screening measures three protein markers: hemoglobin, calprotectin, and serpin family F member 2, in contrast to the regular FIT that only measures hemoglobin. In a retrospective diagnostic accuracy study in a large colonoscopy-controlled series (n =1284), mtFIT showed increased sensitivity for advanced neoplasia (AN), at equal specificity, compared to FIT (42.9% versus 37.3%; p = 0.025). This increase was mainly due to a higher sensitivity of mtFIT for advanced adenomas (37.8% versus 28.1% for FIT; p = 0.006).
CRCbioscreen is currently conducting the mtFIT study, together with its academic partners, i.e. the Netherlands Cancer Institute, Amsterdam University Medical Center and Erasmus Medical Center,. This prospective intervention study aims to validate the earlier retrospective findings. The mtFIT study is a cross-sectional intervention study with a paired design. To this end, 13,000+ participants in the Dutch FIT-based national CRC screening program are invited to perform mtFIT in addition to FIT. Two separate samples from the same bowel movement are collected and shipped to a central laboratory by postal mail. If either mtFIT or FIT is positive, participants are referred for colonoscopy. Detailed colonoscopy and pathology data are centrally collected in the Dutch national screening database ScreenIT, that is managed by the Dutch screening organization, and that will be available for this study.
The study will determine the relative sensitivity for AN (comprising CRC, advanced adenomas and advanced serrated polyps) of mtFIT compared to FIT at an equal positivity rate. In addition, the Adenoma and Serrated pathway to Colorectal CAncer microsimulation model (ASCCA) will be used to predict lifetime health effects and costs for programmatic mtFIT- versus FIT-based screening.
Enrollment of the targeted 13,000+ participants has been completed. Data collection is expected to be completed in Q2, 2023.