Renal Cell Carcinoma, Urothelial Carcinoma
Conditions
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 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.
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 carcinoma and urothelial cancer in Germany. The registry will follow patients with advanced renal carcinoma for up to three years, patients with advanced urothelial cancer for up to two years and patients with muscle-invasive bladder cancer for up to five years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented. Moreover, data on perioperative therapies in patients with high-risk muscle-invasive urothelial carcinoma and radical surgery will be collected. Additionally for patients with muscle-invasive bladder cancer data on (neo)adjuvant systemic therapies and details on surgeries will be collected. Health-related quality of life (HRQoL) in patients with advanced renal cell carcinoma or advanced urothelial cancel will be evaluated for up to two years.
Interventions
Physician's choice according to patient's needs.
Sponsors
iOMEDICO AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Course of treatment (treatment reality) | 3 years per patient | Documentation of anamnestic data and therapy sequences |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Response | 3 years per patient | Documentation of response rates per line of treatment. |
| Progression-free survival | 3 years per patient | Documentation of progression-free survival per line of treatment. |
| Overall survival | 3 years per patient | Documentation of overall survival time. |
| Health-related quality of life (Patient-reported outcome) | 2 years per patient | Cohort aRCC: National Comprehensive Cancer Network/ Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Cohort aUBC: NCCN/FACT Bladder Symptom Index (NCCN-FACT FBlSI-18, Version 2) |
| Treatment symptom related quality of life | 2 years per patient | Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) - Items/Scores cohort aRCC: 3/7/15/22/24/27/28/50/51; Items/Scores cohort aUBC: 3/7/15/22/24/27/28/39/45/50/51 |
Countries
Germany
Contacts
CONTACTMichaela Koska
STUDY_CHAIRMichael Staehler, Prof. Dr.
Ludwig Maximilian University of Munich, Dept. of Urology - University Hospital, Munich, Germany
STUDY_CHAIRPeter Goebell, Prof. Dr.
University Clinic Erlangen, Department of Urology Comprehensive Cancer Center Erlangen EMN, Erlangen, Germany
STUDY_CHAIRLothar Müller, Dr.
Onkologie UnterEms, Leer-Emden-Papenburg, Leer, Germany
STUDY_CHAIRViktor Grünwald, Prof. Dr.
University Hospital Essen West German Cancer Center Essen, Clinic for Medical Oncology and Clinic for Urology, Essen, Germany
STUDY_CHAIRCarsten Grüllich, Prof. Dr.
Sana Clinic Hof, Dept. of Hematology and Oncology, Hof, Germany
STUDY_CHAIRChristian Gratzke, Prof. Dr.
University Hospital Freiburg, Dept. of Urology, Freiburg, Germany
Outcome results
None listed