NCT03374267Recruiting
Registry Platform Urologic Cancer
Clinical Research Platform On Urologic Cancer Treatment And Outcome (Registry Platform Urologic Cancer; CARAT)
Source: ClinicalTrials.gov · Last updated 14 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2230 (estimated)
- First submitted
- 12 Dec 2017
- Start date
- 7 Dec 2017
- Primary completion date
- 31 Mar 2034
- Lead sponsor
- iOMEDICO AG
- Diseases
- Kidney cancer, Bladder cancer
- NCT number
- NCT03374267
What you commit to
- Study type: Observational
- Planned participants: 2230
- From 7 Dec 2017 to the primary completion date, 31 Mar 2034
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with prior systemic therapy for aRCC or aUBC
- Partial cystectomy or partial nephrectomy of the primary tumor as definitive therapy
Other illness
- Metastatic disease (M1) at the time of surgery
- Cohort MIBC (prospective)
Other
- Cohorts aRCC and aUBC (prospective)
- No systemic treatment for aRCC or aUBC
- Cohort High-risk MIUC (prospective and retrospective)
- Clinically detectable metastases (M1) at the time of diagnosis.
- Treatment in palliative intention (for tumors considered inoperable).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Multiple sites, Germany Coordinator of this site? Confirm its status | Multiple Locations | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.