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.
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.
Study Type
OBSERVATIONAL
Enrollment
2,230
Physician's choice according to patient's needs.
Multiple sites, Germany
Multiple Locations, Germany
RECRUITINGCourse of treatment (treatment reality)
Documentation of anamnestic data and therapy sequences
Time frame: 3 years per patient
Best Response
Documentation of response rates per line of treatment.
Time frame: 3 years per patient
Progression-free survival
Documentation of progression-free survival per line of treatment.
Time frame: 3 years per patient
Overall survival
Documentation of overall survival time.
Time frame: 3 years per patient
Health-related quality of life (Patient-reported outcome)
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)
Time frame: 2 years per patient
Treatment symptom related quality of life
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
Time frame: 2 years per patient
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