Professor
Sisse Helle Njor
Biochemistry and Immunology, Lillebaelt Hospital
| Projekt styring | ||
| Projekt status | Open | |
| Data indsamlingsdatoer | ||
| Start | 29.04.2024 | |
| Slut | 31.12.2027 | |
DIOPTRA - Early dynamic screening for colorectal cancer via novel protein biomarkers reflecting biological initiation mechanisms
Short summary
DIOPTRA aims to introduce a screening tool for colorectal cancer that will consider risk factors and biomarkers for pinpointing individuals at high risk for colorectal cancer (CRC) incidence. Other data (e.g. medical, behavioral) will also be considered as potential risk factors. Artificial intelligence (AI) will be leveraged for assessing prognostic power.
Rationale
DIOPTRA aims for an accessible and less taxing screening to attain a wider population outreach by exploiting blood-based biomarkers. Although several researchers have tried to assess this, the limitations in the number of participants and number of proteins studied hinder a generalised framework for early CRC screening and prevention. The same applies in AI-enabled CRC risk assessment, where clinical validation of established systems is absent. DIOPTRA focuses on fulfilling the role of biomarker identification and risk factor stratification via validation on 8 different sites, utilising a large number of patients/ healthy citizens. As such, the evidence produced will not only be based on expert opinion but from vigorous validation procedures on the retrospective and prospective data. The study's retrospective part hypothesised that a set of predictive variables is associated with the risk of developing CRC. Based on this study, risk factors will be identified to investigate their association with CRC and predict the early risk of CRC. Data from electronic health records will be used and analysed to isolate variables defined as risk factors based on four groups, healthy, non-advanced adenomas, advanced adenomas and colorectal cancer. Various methodologies, including statistical analysis and machine learning techniques, will be used to investigate the impact of each factor on CRC. More importantly, by employing cutting-edge in vitro protein analysis in (paired with the blood samples collected) biopsies, the molecular mechanism of CRC development will be uncovered, providing additional evidence needed and thus establishing a robust and efficient framework for early screening.
Description of the cohort
Inclusion criteria: ▪ Any indication for total colonoscopy (including routine screening and presence of symptoms/ FIT positive). ▪ Age between 18-80 years at the moment of recruitment ▪ Absence of significant comorbidities (ASA IV) ▪ Ability to provide valid (written informed) consent
Data and biological material
Blood samples, questionnaire data and data from the patient records.