Renal Cell Carcinoma Clinical Trial
— CARATOfficial title:
Clinical Research Platform On Urologic Cancer Treatment And Outcome (Registry Platform Urologic Cancer; CARAT)
NCT number | NCT03374267 |
Other study ID # | iOM-110363 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | December 7, 2017 |
Est. completion date | June 2027 |
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.
Status | Recruiting |
Enrollment | 1750 |
Est. completion date | June 2027 |
Est. primary completion date | June 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Multiple sites, Germany | Multiple Locations |
Lead Sponsor | Collaborator |
---|---|
iOMEDICO AG |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Course of treatment (treatment reality) | Documentation of anamnestic data and therapy sequences | 3 years per patient | |
Secondary | Best Response | Documentation of response rates per line of treatment. | 3 years per patient | |
Secondary | Progression-free survival | Documentation of progression-free survival per line of treatment. | 3 years per patient | |
Secondary | Overall survival | Documentation of overall survival time. | 3 years per patient | |
Secondary | 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 | |
Secondary | Treatment symptom related quality of life | Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAEâ„¢) - 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 |
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