Clinical registries

In close connection to this national population registry the CSO ensures the running of other clinical registries following mainly the most expensive anti-tumour treatment and its results. In individual complex oncological centres registries following the quality of provided care are also being established.

The Czech Society for Oncology approaches expensive biological treatment with great responsibility. The CSO in cooperation with the Biostatics and Analysis Institute of the Masaryk University (IBA), Masaryk Oncological Institute and Complex Oncological Centres keeps long-term registries of expensive care, namely of the following medicines: trastuzumab, lapatinib, bevacizumab, cetuximab, erlotinib, pemetrexed, sunitinib, sorafenib, cetuximab a imatinib.

Two basic principles are adhered to when working with the registries – prediction (estimation of the number of patients treated in future years) and retrospect (following the process and results of expensive treatment). The retrospective data assesses such aspects of treatment as correct indication of the observed therapy, the process of therapy and its safety, the causes of premature ending and its frequency, immediate and long-term results of treatment. Collective of authors from CSO and IBA elaborated an analysis of all the mentioned drug registries (as of December 15 2008) which states that expensive treatment is distributed among oncological patients in a controlled manner, and only to those patients with fully finalized diagnosis. Biological treatment is only given to patients whose general state allows them to profit from the care offered.

Avastin Project

Avastin Project

The Avastin project was launched in 2005 as a clinical registry of patients with advanced colorectal carcinoma, who have been treated with Avastin - a biological agent which specifically inhibits angiogenesis in the tumour tissue. This drug registry aims to monitor the total number of patients treated with Avastin and to collect epidemiological and clinical data of patients in order to assess the safety and effectiveness of treatment with this biological product. Moreover, Avastin is due to be used in the anticancer therapy of breast and lung carcinoma since 2008, thus enabling the epidemiological characteristics of patients, analysis of treatment response, modelling the influence of risk factors on patients´ survival, as well as the detailed analysis of reported adverse effects within three different diagnoses.

ERBITUX Project

ERBITUX Project

The ERBITUX project monitors the effectiveness of treatment with the targeted biological therapy Erbitux, which is currently used for the indications of metastatic colorectal cancer and locally advanced squamous cell carcinoma of head and neck. The project belongs to the category of drug registries and is supported by the Board of the Czech Oncological Society. The project involves two separate registries, as there are two main groups of monitored patients: those with colorectal cancer and those with head and neck carcinoma.

Herceptin Project

Herceptin Project

The Herceptin project was launched in 2005 as a clinical registry of patients with breast carcinoma, who have been treated with Herceptin. At the start of the project, only patients with metastatic breast carcinoma were included in the study. Since 2006, however, Herceptin can be used to treat breast carcinoma of less advanced stages, and patients treated with Herceptin in adjuvant therapy are included as well. The project is focused on the collection of patients´ epidemiological and clinical data in order to assess treatment safety and effectiveness, monitoring the treatment response and defined survival parameters. In December 2007, the Herceptin registry contained more than 800 records of patients treated with Herceptin, which is a clinically significant dataset from the population point of view.

Interb Project

Interb Project

The project will cover nine countries (Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania, Slovakia, Slovenia, and Ukraine).

Project GIST

GIST is a clinical registry which monitors epidemiology, treatment and treatment results of patients with gastro-intestinal stromal tumours (GIST) in the Czech Republic and Slovakia. The basic inclusion criterion is a verified diagnosis of gastro-intestinal stromal tumour, not the application of a specific drug.

The project was prepared in cooperation with the coordinating investigators from health centres experienced in diagnosis and treatment of GIST. After several years of investigation, we would like to offer participation in this project to more centres in the Czech Republic, Slovakia and possibly other countries. The project and its ICT background are distinctly modular, arranged by individual diagnosis groups. Fully de-identified data are collected, which excludes any direct or indirect identification of the subjects.

Project Pemetrexed

The Pemetrexed project is a clinical registry of patients with non-small cell lung cancer (NSCLC) or mesothelioma who have been treated with pemetrexed. The Czech Society for Oncology (CSO) and the Czech Pneumological and Phthiseological Society (CPPS) are expert guarantors of this project. Objectives of the project involve monitoring treatment safety and effectiveness, making it possible to analyze epidemiological characteristics of cancer patients and their treatment response, to model the influence of risk factors on survival, and to perform a detailed analysis of adverse reactions. Moreover, the project has become one of the projects that assess and monitor health care results and quality within the Czech National Cancer Control Programme; therefore, this project will also aim to improve the quality of life of patients with lung carcinoma and mesothelioma.

Project Renis

The primary goal of the RENIS project (RENal Carcinoma – Information System) is to create a parametric database and information system for the collection and analysis of data on patients with malignant neoplasm of kidney.

The data structure of the system contains all necessary items to meet the standards on parametric monitoring of patients with renal carcinoma: records on diagnosis are monitored primarily, including main risk factors and prognostic factors; moreover, the course of therapy is recorded, including the description of results and possible complications.

Project Tarceva

Project Tarceva

The Tarceva project was launched in January 2008 as a clinical registry of patients with advanced non-small cell lung cancer (NSCLC) who have been treated with Tarceva. The Czech Oncological Society (COS) and the Czech Pneumological and Phthiseological Society (CPPS) are expert guarantors of this project. Objectives of the Tarceva project involve monitoring treatment safety and effectiveness, making it possible to analyze epidemiological characteristics of cancer patients and their treatment response, to model the influence of risk factors on survival, and to perform a detailed analysis of adverse reactions. During 2008, Tarceva usage will be further extended to treat pancreatic carcinoma. Moreover, the Tarceva project has become one of the projects which assess and monitor health care results and quality within the Czech National Cancer Control Programme; therefore, this new project will also aim to improve the quality of life of patients with lung carcinoma and pancreatic carcinoma, and to make the best use of available resources for these patients´ treatment.

Project Yondelis

The Yondelis project was launched in January 2011 to obtain basic information on epidemiology of soft tissue sarcomas, standard treatment procedures and results of treatment with trabectedin in standard clinical practice. The project is guaranteed by the Czech Society for Oncology at the CzMA and representatively covers network of Cancer Centres that comprehensively deal with treatment of soft tissue sarcomas.

Records of patients with confirmed diagnosis and initiated treatment including trabectedin therapy in years 2008–2010 were entered into the database retrospectively as well. Data collection is fully anonymous and does not affect a treatment scheme determined by the physician, or treatment availability.

Registry.cz

This website is administered and updated by the Institute of Biostatistics and Analyses (IBA) at the Masaryk University, with the objective to provide information on creation and administration of clinical registries maintained at this academic institute. The aim of the www.registry.cz portal is to provide methodical guidelines to subjects interested in clinical registry establishment and administration.

You can find here an overview of all registry projects at IBA, as well as general information and advice on the establishment and administration of clinical registries (registry design, legal aspects, safety requirements etc.).