Prospective Collection of Samples for Urothelial Cancer of Bladder

ProCSUCaB (Prospective Collection of Samples for Urothelial Cancer of Bladder) is a monocentric, non-interventional, prospective registry that will recruit newly diagnosed intermediate- and high-risk NMIBC patients in a tertiary center in Flanders.

Clinical data and biosamples (blood, urine, and BC tissue) will be collected from each patient at the initial diagnosis before the surgery and will be stored at -80 °C at the BioBank UZ Leuven after proper processing according to the protocol. High-throughput multi-omics (genomics, epigenomics, transcriptomics, proteomics, lipidomics, metabolomics) and immunohistopathology analyses will be performed on these samples.

Patients of both sex and aged ≥18 years, with a signal of clinical diagnosis of BC (symptoms and/or imaging), are eligible to participate in this study. Patients, who give their informed consent to collect their biological materials prior to surgery, will be included in the study after the histopathological diagnosis of the TURBT specimen shows an intermediate- or high-risk NMIBC. Only the data of the patients with a TCC, with the allowance of any variant histopathological subtype, will be analyzed.

All patients will be treated and followed up with the standard of care based on the recommendations of the EAU Guidelines according to their risk groups. All follow-ups will be scheduled for 5 years as most of the recurrences or progressions occur during this period.

To comply with local privacy laws, all demographic and clinical data (for initial diagnosis and following recurrences and/or progressions) will be prospectively stored in a specific database, which is implemented into the hospital's electronic patient file system, and protected by firewalls [24]. All patients will receive a study identification number, and names (or any other identifying data) will be removed from the collected biosamples; therefore, all -omics and pathology laboratories will not know the identity and clinical data of the patients. The correspondence between the study identification numbers and patient names will be kept by only the urology department in a secured database.