Clinical Research Platform On Urologic Cancer Treatment And Outcome (Registry Platform Urologic Cancer; CARAT)
The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study with associated satellites, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with advanced renal cell carcinoma or urothelial cancer in Germany.
∙ Cohorts aRCC and aUBC (prospective)
• Female and male patients with aRCC or aUBC (locally advanced, inoperable or metastatic)
• Patients at start of their first-line systemic treatment for aRCC or aUBC
• Written informed consent
‣ Patients participating in the PRO module: signing of in-formed consent form and completion of baseline questionnaire before start of initial systemic treatment
⁃ Patients not participating in the PRO module: within twelve weeks after start of systemic first-line for aRCC or aUBC
• Age ≥ 18 years
∙ Cohort High-risk MIUC (prospective and retrospective)
• Histologically proven muscle-invasive urothelial carcinoma (MIUC) of the lower or upper urinary tract (ICD-10 C65, C66, C67.x, C68.x). Mixed histologies are allowed (main compo-nent must be urothelial carcinoma, with minor variants accept-ed).
• Radical surgery (e.g., radical cystectomy, nephroureterecto-my) between October 1, 2021 and October 31, 2024.
• High-risk of recurrence, defined as follows: Post-operative, pathological tumor status
‣ ypT2-ypT4 and/or ypN+ and without clinically detectable metastases (M0) at cystectomy for patients with prior neo-adjuvant chemotherapy or
⁃ pT3-pT4 and/or pN+ and without clinically detectable me-tastases (M0) at cystectomy for patients without prior neo-adjuvant chemotherapy.
• Age ≥ 18 years at the time of surgery.
• Written informed consent (only if patient is alive at time of data entry; not applicable for inclusion of deceased patients' data)