Registry Platform Urologic Cancer

Renal Cell Carcinoma Clinical Trial

— CARAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03374267
• Other study ID #: iOM-110363
• Status: Recruiting
• Start date: December 7, 2017
• Est. completion date: June 2027

Study information

• Verified date: March 2024
• Source: iOMEDICO AG
• Contact: Michaela Koska
• Phone: +49 761 15242-0
• Email: info[@]iomedico.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma
• Urologic Neoplasms
• Urothelial Carcinoma

Intervention

Other:
• Routine care as per site standard.
Physician's choice according to patient's needs.

Locations

Country	Name	City	State
Germany	Multiple sites, Germany	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
iOMEDICO AG

Country where clinical trial is conducted

Germany, 

Outcome

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-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