Clinical Research Platform On Urologic Cancer Treatment And Outcome (Registry Platform Urologic Cancer; CARAT)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Renal Cell Carcinoma
- Sponsor
- iOMEDICO AG
- Enrollment
- 1930
- Locations
- 1
- Primary Endpoint
- Course of treatment (treatment reality)
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Patients with prior systemic therapy for aRCC or aUBC
- •No systemic treatment for aRCC or aUBC
Outcomes
Primary Outcomes
Course of treatment (treatment reality)
Time Frame: 3 years per patient
Documentation of anamnestic data and therapy sequences
Secondary Outcomes
- Best Response(3 years per patient)
- Treatment symptom related quality of life(2 years per patient)
- Health-related quality of life (Patient-reported outcome)(2 years per patient)
- Progression-free survival(3 years per patient)
- Overall survival(3 years per patient)