Research and projectsContract research projects

Contract research projects RenIS

Duration Duration: 2007–2018

Contracting authority Contracting authority: Czech Society for Oncology

Clinical registry of kidney cancer patients who have been treated with bevacizumab (Avastin®), everolimus (Afinitor®), pazopanib (Votrient®), sorafenib (Nexavar®), sunitinib (Sutent®) and/or temsirolimus (Torisel®).

The RenIS registry (Renal carcinoma Information System) is a non-interventional post-authorization trial focused on the collection of epidemiological and clinical data on kidney cancer patients treated with biological therapies in the Czech Republic. At present, the registry monitors kidney cancer treatment with bevacizumab (Avastin®), everolimus (Afinitor®), pazopanib (Votrient®), sorafenib (Nexavar®), sunitinib (Sutent®) and temsirolimus (Torisel®). The project was initiated in June 2007 at the Institute of Biostatistics and Analyses of the Masaryk University (IBA MU) and has continued at the Institute of Biostatistics and Analyses Ltd (IBA Ltd), a university company.

The obtained data will allow researchers to monitor the epidemiological characteristics of kidney cancer patients as well as applied treatment regimens, to analyze patients’ response to treatment, to model the influence of risk factors on patients’ survival and a to perform detailed analyses of recorded adverse effects.

Although the applied data collection system is primarily focused on treatment of advanced disease and of disseminated relapses, it also involves all significant data related to the primary tumour. The universal and generally valid data structure of the registry allows researchers to follow any treatment pattern in a logical context of disease progression, while taking into account the influence of factors which significantly affect treatment results.

The project is open to cooperation with all Comprehensive Cancer Centres in the Czech Republic. The system is based on an on-line technology which enables a high-quality central management and administration of data from individual centres while respecting their rights as unique owners of their clinical data. The flexibility and openness of the on-line system for data collection and assessment allows further extensions to specific items.

Primary objectives of the project:

  • monitoring the overall number of kidney cancer patients in the Czech Republic treated with sorafenib, sunitinib, temsirolimus, everolimus, bevacizumab a pazopanib,
  • assessment of safety of the above-mentioned drugs,
  • assessment of effectiveness of the above-mentioned drugs and of applied treatment regimens.

Secondary objectives of the project:

  • analysis of patients’ survival in relation to monitored clinical factors,
  • analysis of patient cohort treated with biological therapies in relation to Czech reference population data.

Other important information:

  • Expert guarantor: Katarína Petráková, MD, PhD (Czech Society for Oncology)
  • Partners: 20 specialized centres in the Czech Republic (you can find more detailed information on the website of the Renis project)
  • Brief overview of results: you can find more detailed information on the website of the RENIS project
RENIS: clinical registry of patients with malignant neoplasm of kidney