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Endpoints

Clinical Endpoints

Molecular biomarker testing, treatment and outcome registry of patients with high risk pTa NMIBC, pT1 NMIBC & MIBC in Germany.

  • Data on the frequency, and methodology of decentral (routine) histopathological and biomarker testing
  • Comparison with central histopathological & molecular testing of subtypes, targets and immune infiltrates at specialzed sites
  • Systemic treatments and sequential treatments as applied in real-life practice
  • Efficacy of loco-regional (e.g. instillation) and systemic treatments regarding general and specific outcome parameters (e.g. response rate, recurrence free survival, PFS, OS)
  • Safety of current treatment approaches

Pathologic Endpoints

Example: Histopathological and molecular testing

  • Histological type
  • WHO grade (1973 & 2004)
  • Tumor size, nodal status, lympho-vascular infiltration
  • Site of initial and subsequent metastasis
  • Immune cell infiltration by histopathology
  • Molecular subtype defined by IHC& RT-qPCR
  • PD-L1 status by IHC & RT-qPCR
  • FGFR mutation/fusion status
  • Bladder Cancer mutation panel
  • Target gene quantitations by BladderTyper RT-qPCR