Registry Platform Urologic Cancer

Recruiting now

Conditions studied: Renal Cell Carcinoma, Urothelial Carcinoma

In brief

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.

Key facts

Study ID

NCT03374267

Run by

iOMEDICO AG

People needed

2230

Starts

2017-12-07

Expected to finish

2034-03-01

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Multiple sites, Germany — Multiple Locations, Germany (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.