The CODIGE project aims to identify the socio-economic, clinical, biometric, biochemical-clinical, pharmacological and genetic determinants that characterise and differentiate the oncological population aged over 65 from those aged 65 and under. In addition, the project aims to estimate the risk of mortality, hospitalisations for all causes and adverse reactions to oncological and non-oncological drugs in the two age groups. The study is an observational cohort study based on the use of a large database managed by the Clinical Pharmacology Department of the AOU – University of Salerno, which is already available and contains detailed data on: socio-demographic characteristics, oncological history, tumour characteristics, biometric and biochemical-clinical factors, pharmacogenetic variables, oncological and non-oncological treatments, and adverse reactions to drugs. This database will be enriched by collecting data on clinical outcomes (mortality and hospitalisations for all causes) from the Operational Units involved in the project.
The statistical analysis involves comparing the two age groups (>65 years and ≤65 years) using descriptive and inferential analyses. Stratified analyses will also be conducted for the most prevalent cancers in the sample in order to explore any specific differences between cancer subgroups. The expected results of the project will contribute to improving the understanding of the factors that influence the clinical management of the elderly cancer population, providing useful evidence to support personalised therapeutic strategies and more appropriate care pathways with a view to precision geriatric oncology.
In the first reporting period, December 2024 – March 2025, CODIGE completed the definition of the protocol and statistical plan (SAP) for WP1 and started the data quality check on the Oncovigilance Programme database, in preparation for cross-sectional analyses and stratification by tumour subgroups. For WP2, the longitudinal study protocol was reviewed/updated and the amendment was approved by the Ethics Committee of the coordinating centre (30/01/2025), while requests for approval are pending from the other Ethics Committees of the Operational Units. In WP3, the electronic Case Report Form (eCRF) and the operating manual are being developed, with a paper structure already defined to speed up implementation when the platform is activated. There has been a delay of ~45 days in the start of WP3 data collection, due to the time required for ethical approval and the acquisition of the eCRF platform; corrective measures have been taken (close monitoring, paper definition of the eCRF) and the impact is considered limited/manageable. The initial deliverables are in line with forecasts; there is a duplication of label D4 in WP3 (interim report and statistical report), which is likely a typo to be clarified during reporting.