Registry Platform Urologic Cancer

  • STATUS
    Recruiting
  • End date
    Oct 4, 2026
  • participants needed
    1500
  • sponsor
    iOMEDICO AG
Updated on 4 November 2021
cancer
carcinoma
urinary tract cancer
advanced renal cell carcinoma

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.

Details
Condition Transitional cell carcinoma, clear cell renal cell carcinoma, Renal Cell Carcinoma, Kidney Cancer, Malignant neoplasm of kidney, Renal Cancer, Renal Cell Cancer, Adenocarcinoma, Urothelial Carcinoma, Malignant Adenoma
Treatment Routine care as per site standard.
Clinical Study IdentifierNCT03374267
SponsoriOMEDICO AG
Last Modified on4 November 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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