Registry Platform Urologic Cancer

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

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)

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

Conditions3

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