Registry Platform Urologic Cancer
- Conditions
- Renal Cell CarcinomaUrothelial Carcinoma
- Interventions
- Other: Routine care as per site standard.
- Registration Number
- NCT03374267
- Lead Sponsor
- iOMEDICO AG
- 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 advanced 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, and patients with advanced urothelial cancer for up to two 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.
Health-related quality of life (HRQoL) in patients with renal cell carcinoma or urothelial cancel will be evaluated for up to two years.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1750
-
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
- Patients with prior systemic therapy for aRCC or aUBC
- No systemic treatment for aRCC or aUBC
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description aRCC Routine care as per site standard. Patients with advanced renal cell carcinoma aUBC Routine care as per site standard. Patients with advanced urothelial carcinoma (locally advanced and inoperable, or metastatic) High-risk MIUC Routine care as per site standard. 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)
- Primary Outcome Measures
Name Time Method Course of treatment (treatment reality) 3 years per patient Documentation of anamnestic data and therapy sequences
- Secondary Outcome Measures
Name Time Method Best Response 3 years per patient Documentation of response rates per line of treatment.
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
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)
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.
Trial Locations
- Locations (1)
Multiple sites, Germany
🇩🇪Multiple Locations, Germany