National registry for patients with advanced kidney and bladder cancer
Clinical Research Platform On Urologic Cancer Treatment And Outcome (Registry Platform Urologic Cancer; CARAT)
This study is setting up a national registry to track the experiences and treatments of patients with advanced kidney and bladder cancer over a few years to help improve care and research in the future.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1930 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | iOMEDICO AG Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Multiple Locations) |
| Trial ID | NCT03374267 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adult patients with locally advanced, inoperable, or metastatic renal cell carcinoma or urothelial carcinoma who are starting their first-line systemic treatment.
Not a fit: Patients with early-stage or operable renal cell carcinoma or urothelial carcinoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could enhance understanding of treatment patterns and improve patient outcomes for those with advanced renal cell carcinoma and urothelial cancer.
How similar studies have performed: Other observational studies have successfully established cancer registries, indicating that this approach has potential for meaningful contributions to cancer treatment understanding.
Eligibility criteria
Show full inclusion / exclusion criteria
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) 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
Where this trial is running
Multiple Locations
- Multiple sites, Germany — Multiple Locations, Germany (Recruiting)
Study contacts
- Study coordinator: Michaela Koska
- Email: info@iomedico.de
- Phone: +49 761 15242-0
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.