High-definition study to identify population parameters associated with progression of non-muscle invasive urothelial carcinoma

Urothelial carcinoma of the bladder is the fifth most frequent cancer, and approximately 30,000 new cases are diagnosed annually in Italy. In the majority of cases (about 80%), the disease begins as an organ-confined, non-muscle-invasive form. 

A number of informants concerning PD-L1 expression, histological subtype according to the Cancer Genome Atlas (TCGA), mutational and neoantigenic tumour load and immuno-genetic expression are currently being studied both as predictive factors and as biomarkers for the efficacy of new drugs. However, the great heterogeneity of outcome, and the complexity of the treatments provided for non-muscle invasive disease makes reason for an epidemiological exploration to assess a geographical and environmental (social and health) impact on the risk of evolution to muscle invasive stages and metastatic disease. 

The study aims to longitudinally evaluate subjects included in the Italian cancer registries with an initial diagnosis of non-muscle invasive carcinoma and evaluated according to the initial disease characteristics (Sylvester classification, adapted) for a duration of 5 years, with registration of the event progression to muscle infiltrating or metastatic disease (N1 and/or M1). Overall survival, disease-specific survival, use of invasive treatments will also be analysed. 

Several Italian population-based cancer registries of the AIRTUM network are participating in the study with their bladder cancer incidence data.