Clinical trial · Observational
Registry Platform Urologic Cancer
Clinical Research Platform On Urologic Cancer Treatment And Outcome (Registry Platform Urologic Cancer; CARAT)
NCT03374267CI-TRIAL-00117861CARATrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Routine care as per site standard. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- aRCC
- description
- Patients with advanced renal cell carcinoma
- interventionNames
- Other: Routine care as per site standard.
- label
- aUBC
- description
- Patients with advanced urothelial carcinoma (locally advanced and inoperable, or metastatic)
- interventionNames
- Other: Routine care as per site standard.
- label
- High-risk MIUC
- description
- Patients with muscle-invasive urothelial carcinoma classified as high-risk after radical surgery (ypT2-ypT4 and/or ypN+,M0 for patients with prior neoadjuvant chemotherapy; pT3-pT4 and/or pN+, M0 for patients without prior neoadjuvant chemotherapy)
- interventionNames
- Other: Routine care as per site standard.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.