Abstract
BackgroundPrograms for population screening of colorectal cancer (CRC) have been implemented in several countries with fecal immunochemical testing (FIT) as the preferred platform. However, the major obstacle for a feces-based testing method is the limited compliance that reduces the clinical sensitivity for detection of participants with non-symptomatic CRC. Therefore, research approaches have been initiated to develop screening concepts based on biomarkers in blood. Preliminary results show that protein, genetic, epigenetic, and metabolomic components may be valuable in blood-based screening concepts, particularly when combinations of the various components appear to lead to significant improvements.ObjectivesThe protocol described in this paper focuses on the validation of concepts based on biomarkers in blood in a major population screened by FIT.MethodsIn Part 1, participants will be identified and included through the Danish CRC Screening Program comprising initial FIT and subsequent colonoscopy to those with a positive result. Blood samples will be collected from 8000 FIT-positive participants, who are offered subsequent colonoscopy. Findings and interventions at colonoscopy together with personal data including co-morbidity will be recorded. Blood samples and data will also be collected from 6000 arbitrarily chosen participants with negative FIT. In Part 2, blood samples and data will be collected from 30,000 FIT-negative participants three times within 4 years. The blood samples will be analyzed using various in-house and commercially available manual and automated analysis platforms.ResultsWe anticipate Part 1 to terminate late August 2016 and Part 2 to terminate late September 2022. The results from Parts 1 and 2 will be presented within 12 to 18 months from termination.ConclusionsThe purpose of this study is to improve the efficacy of identifying participants with neoplastic bowel lesions, to identify false negative participants, to identify participants at risk of interval neoplastic lesions, to improve the compliance in screening sessions, and to establish guidelines for out-patient follow-up of at-risk participants based on combinations of blood-based biomarkers.
Highlights
Colorectal cancer (CRC) represents the second leading cause of cancer-related death in Europe with a high social and economic impact on human health [1,2]
Direct colonoscopy is considered the gold standard for colorectal cancer (CRC) screening: sensitivity and specificity are higher than 95% for diagnosing neoplastic lesions if performed by experienced colonoscopists [5]
fecal immunochemical testing (FIT) has some limitations, ; the positive predictive value of FIT for diagnosing CRC is in the range of 6% to 10% [7,8,9], and greater than 10 colonoscopies have to be performed in order to diagnose one case of CRC
Summary
Colorectal cancer (CRC) represents the second leading cause of cancer-related death in Europe with a high social and economic impact on human health [1,2]. A focus has been on the development of methods to identify participants having increased risk of CRC in order to selectively offer colonoscopy. The predominant challenge is the association with low patient compliance in the range of 33% to 64% which reduces the clinical sensitivity significantly [9,10], resulting in a large proportion of undiagnosed CRC among participants who have not taken the test in addition to participants with a false negative result of FIT. An urgent need has emerged to develop improved methods for early detection of CRC with high performance regarding sensitivity and improved compliance. The major obstacle for a feces-based testing method is the limited compliance that reduces the clinical sensitivity for detection of participants with non-symptomatic CRC. Preliminary results show that protein, genetic, epigenetic, and metabolomic components may be valuable in blood-based screening concepts, when combinations of the various components appear to lead to significant improvements
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
