Clinical Trial Information Sheet - CARAT

Primary Indication
Renal cell carcinoma and urothelial/bladder carcinoma (renal cell carcinoma and urothelial arms combined)
Study Name (Study Type)
CARAT (registry platform)
Study sponsor
IOMEDICO
Registration number
ClinicalTrials.gov Identifier: NCT03374267
FOR SKIM READERS:
Study for patients with advanced, inoperable, or metastatic renal cell carcinoma (RCC) as well as advanced, inoperable, or metastatic urothelial/bladder cancer (UBC). Treatment data, questionnaires, and tissue samples from the patients’ tumors will be collected for future research projects. This is an observational study and will not influence the treatment prescribed by the physician.
DETAILED INFORMATION
The aim of this study is to document treatment practices, with a particular focus on how they have evolved over the years, as well as to describe the factors that lead to treatment decisions and to analyze and evaluate the effectiveness of therapies and the associated assessment of health-related quality of life.
Study Title
CARAT Urological Tumors Registry Platform
Which diseases are covered by the study?
Renal Cell Carcinoma (RCC)
Urothelial/Bladder Cancer (UBC)
Are specific subgroups of patients with one of the listed diseases being treated?
No
Background on the study medication
None
Study Protocol.
Patients are asked to complete a questionnaire before the start of first-line treatment and then every 3 months for up to 2 years, as well as to provide their consent for the use of routinely collected tissue samples for future research projects.
Inclusion Criteria
- Patients with renal cell carcinoma or urothelial/bladder carcinoma requiring treatment (localized, advanced, inoperable, or metastatic)
- Patients at the start of their first-line systemic treatment
- Patients who are 18 years of age or older
Exclusion Criteria
- Patients who have previously received systemic therapy
- No prior systemic therapy
- The patient is simultaneously participating in a clinical trial and receiving active treatment
Your contacts: Investigators at the center and contact information
Dr. Guido Platz
Email: platz@~@gp-ruesselsheim.de
Contact the Clinical Trial Clinic
Heike Borchert (Study Coordinator)
Email: Studienambulanz@gp-ruesselsheim.de
Phone: 0162-1392714