The TULUNG registry is a non-interventional post-registration database focused on the collection of epidemiological and clinical data of patients with non-small cell lung carcinoma (NSCLC) who have been treated with targeted agents. The project was initiated in July 2011 by the Czech Society for Oncology. Obtained data allow for monitoring of NSCLC patients' treatment and its results. Institute of Biostatistics and Analyses Ltd, a spin-off company of the Masaryk University, provides management and other services to this project.
Primary goals
- Documentation of treatment of patients with NSCLC treated with targeted agents in the Czech Republic
- Assessment of effectiveness of treatment and regimens used
- Evaluation of safety of the targeted therapy
Secondary goals
- Analysis of patients survival in relation to monitored clinical factors
- Analysis of the patients cohort treated with targeted therapy in relation to reference population-based data
Background
In association with increasing number of the targeted therapies approved for treatment of NSCLC, several clinical registries have been developed, which were focused on treatment with individual targeted agents for this indication. Board of the Czech Society for Oncology at the CzMA therefore agreed to solve this situation by development of a new registry, which would integrate data collected within the frame of previous projects. Thus, the TULUNG registry has currently served for monitoring of treatment by six targeted agents together - bevacizumab (Avastin), erlotinib (Tarceva), gefitinib (Iressa), pemetrexed (Alimta), afatinib (Gilotrif) and nintedanib (Vargatef). In case of approval of further drugs for the treatment of NSCLC, these will be easily included in the registry structure.
Witin the frame of the original registries integration, previously collected data were transferred into the new NSCLC registry structure. The integration has removed necessity to enter data on particular patient's treatment into different registries, which allows for obtaining comprehensive and transparent information about overall treatment of the patient, monitoring of therapy sequences and patient's response to the treatment.
The project will undoubtedly increase quality and effectiveness of data collection and simplify work of registry users. Besides of patients' epidemiological characteristics, it will also allow for modelling of risk factors for patients' survival and analysis of adverse effects. The registry may also serve for economical purposes and estimations, such as planning of costs for anticancer treatment.
