Urothelial carcinoma of the urinary bladder, ureter, or kidney. C65 C66 C67 C68
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with urothelial carcinoma (MIUC) (= pT2 or pT1 cN+) o Patients who have undergone radical cystectomy (RC) or nephroureterectomy (NUX). o Patients who declined radical cystectomy or nephroureterectomy, or were not eligible for these procedures. o Alternative bladder-preserving treatment using trimodal therapy or TUR-B; additionally, patients receiving best supportive care. Age = 18 years
Exclusion criteria
Exclusion criteria: Presence of distant metastases (M1) at the time of initial diagnosis. Previous radical cystectomy (RC) or nephroureterectomy (NUX) (i.e., no primary cases). Lack of histopathological confirmation of the diagnosis. Other dominant malignant disease unless it has been completely treated with curative intent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WHAT is the endpoint (target criterion)? Overall survival (OS), defined as the time from diagnosis or initiation of therapy to death from any cause. WHEN is this parameter checked? At baseline and during routine follow-up visits until death or last known contact. HOW is data collected (e.g. questionnaire XY)? Data are collected retrospectively from electronic medical records and hospital information systems, including clinical documentation and survival status obtained from follow-up records. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS): time from diagnosis or initiation of therapy to the occurrence of tumour progression (local, regional, or distant metastasis) or death from any cause, whichever occurs first. In addition, clinical and pathological factors as well as prognostic predictors will be analysed in relation to overall survival and progression-free survival. WHAT is the endpoint (target criterion)? Progression-free survival (PFS), defined as the time from diagnosis or initiation of therapy to the occurrence of tumour progression (local, regional, or distant metastasis) or death from any cause, whichever occurs first. In addition, clinical and pathological factors as well as prognostic predictors will be analysed in relation to overall survival and progression-free survival. WHEN is this parameter checked? At baseline and during routine clinical and radiological follow-up according to standard care. HOW is data collected (e.g., questionnaire XY)? Data are collected retrospectively from medical records, including radiology reports, pathology findings, and clinical follow-up documentation. | — |
Countries
Germany
Contacts
Universitätsklinikum Essen - Urologie