Status:
RECRUITING
Registry Platform Urologic Cancer
Lead Sponsor:
iOMEDICO AG
Conditions:
Renal Cell Carcinoma
Urothelial Carcinoma
Eligibility:
All Genders
18+ years
Brief 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 characteristi...
Detailed Description
CARAT is a national, observational, prospective, longitudinal, multicenter cohort study (tumor registry platform) with the purpose to record information on the antineoplastic treatment of renal cell c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 7 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
1930 Patients enrolled
Trial Details
Trial ID
NCT03374267
Start Date
December 7 2017
End Date
September 1 2028
Last Update
September 22 2025
Active Locations (1)
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1
Multiple sites, Germany
Multiple Locations, Germany