National registry for patients with advanced kidney and bladder cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to establish a national, prospective, longitudinal cohort study in Germany to document uniform data on the characteristics, molecular diagnostics, treatments, and disease progression of patients with advanced renal cell carcinoma and urothelial cancer. The registry will follow patients for up to three years for renal cancer and two years for bladder cancer, collecting comprehensive data on treatments, outcomes, and patient-reported quality of life. It will also create a decentralized biobank to support future research in these cancers.

Why it matters

Who can join: the full rules

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).

Where it's running

• Multiple sites, Germany
  Multiple Locations, Germany Recruiting

Study contacts

• Study coordinator: Michaela Koska
• Email: info@iomedico.de
• Phone: +49 761 15242-0

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.