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Clinical Trial Details — Status: Recruiting

Administrative data

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

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
Health authority
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

Study Design


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-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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