Directory of registries

Clinical registry of melanoma patients who have been treated with dabrafenib (Tafinlar®), ipilimumab (Yervoy®), nivolumab (Opdivo®), trametinib (Mekinist®), pembrolizumab (Keytruda®) and/or vemurafenib (Zelboraf®).

start of the project: January 2013

The MELANOM project is a multicentre, non-interventional, observational, prospective study, which monitors the administration of biological therapies to melanoma patients. The system evaluates not only therapeutic procedures and results for monitored drugs, but also potential sequences of targeted therapies. All cancer centres providing biological therapies for melanoma are involved in the project. The system is open for additional participants who might be interested in it.

Registration of clinical data is centrally managed and its objectives are not only aimed at scientific research. An agreement on parametric assessment of the treatment process made it possible to develop treatment guidelines, to define entry criteria for treatment start, and to assess the treatment response correctly.

Continuous data assessment and feedback are provided to physicians and health care management, meeting the requirements of evidence-based medicine. Patient rights are fully respected and data collection is anonymous (de-identified), i.e. it does not involve any personal data.

The selection of patients to be recorded into the registry falls within the competence of his/her treating oncologist. The indication of diagnostic and/or therapeutic procedures, prescription of drugs, monitoring and all other treatment decisions are not linked to this project in any way, and the treating oncologist is fully responsible for any of these actions.

The project was initiated 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.

Primary objective of the project:

  • monitoring the overall number of melanoma patients in the Czech Republic treated with dabrafenib, ipilimumab, nivolumab, trametinib, pembrolizumab and/or vemurafenib

Secondary objectives of the project:

  • assessment of effectiveness of targeted therapies and of applied treatment regimens,
  • analysis of patients’ survival in relation to monitored clinical factors,
  • assessment of safety of targeted therapies.

Other important information:

  • Expert guarantor: Katarína Petráková, MD, PhD (Czech Society for Oncology)
  • Partners: 20 cancer centres in the Czech Republic