Routine care as per site standard.: Physician's choice according to patient's needs.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
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)
Cohort MIBC (prospective)
* Diagnosis of MIBC (muscle-invasive bladder cancer; ICD-10 C67.x; cT2-T4aN0M0 or T1-T4aN1M0).
* Histologically proven muscle-invasive urothelial carcinoma. Mixed histologies are allowed (main component must be urothelial histology, with minor variants accepted).
* Age ≥ 18 years at the time of diagnosis.
* Written informed consent within 15 weeks from diagnosis of MIBC.
Exclusion Criteria:
Cohorts aRCC and aUBC (prospective)
* Patients with prior systemic therapy for aRCC or aUBC
* No systemic treatment for aRCC or aUBC
Cohort High-risk MIUC (prospective and retrospective)
* Partial cystectomy or partial nephrectomy of the primary tumor as definitive therapy
* Metastatic disease (M1) at the time of surgery
Cohort MIBC (prospective)
* Clinically detectable metastases (M1) at the time of diagnosis.
* Treatment in palliative intention (for tumors considered inoperable).
Primary outcome measure(s)
Course of treatment (treatment reality) — 3 years per patient Documentation of anamnestic data and therapy sequences
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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