Registry Platform Urologic Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Research Platform On Urologic Cancer Treatment And Outcome (Registry Platform Urologic Cancer; CARAT)

Conditions
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Renal Cell Carcinoma, Urothelial Carcinoma

Intervention / Treatment
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* Other: Routine care as per site standard.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| aRCC<br>Patients with advanced renall cell carcinoma | Other: Routine care as per site standard.<br>* Physician's choice according to patient's needs.<br>|
| aUBC<br>Patients with advanced urothelial carcinoma | Other: Routine care as per site standard.<br>* Physician's choice according to patient's needs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Course of treatment (treatment reality) | Documentation of anamnestic data and therapy sequences | 3 years per patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Response | Documentation of response rates per line of treatment. | 3 years per patient | 
| Progression-free survival | Documentation of progression-free survival per line of treatment. | 3 years per patient | 
| Overall survival | Documentation of overall survival time. | 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) | 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 | 2 years per patient |