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Project design


Retrospective part
Prospective part
Medicinal products being tested
Data management
Personal data protection
Personal data storage and management
Quality assurance and quality control (QA/QC)
Statistical data processing

Retrospective part

In each involved centre, relevant data concerning SRE incidence and treatment will be gathered retrospectively for 25 consecutive patients with metastatic breast carcinoma diagnosed since the beginning of 2000. The data will undergo a central statistical processing.

Population of patients: All patients with metastatic breast carcinoma and with a minimum 5-year follow-up who have been diagnosed with metastases affecting the skeleton in 2000.

Prospective part

In each project site, 25 consecutive patients with breast carcinoma – diagnosed with metastases affecting the skeleton after the start of this project – will be included prospectively into monitoring. Relevant data concerning the incidence and treatment of skeletal related events will be recorded in a six-month interval. The data will undergo a central statistical processing.

Population of patients: All patients with advanced breast carcinoma who will be diagnosed with metastases affecting the skeleton after the start of this project.

Medicinal product being tested

The ICARUS project is not intended to test any specific product. The project aims to analyse data from a population of patients with advanced breast carcinoma with bone metastases. Various products can be used to prevent skeletal related events (SRE). In case of incidence of a SRE, various therapy methods can be used. All patients treated with any method will be included into the ICARUS project.

Data management

The data can be collected in two ways:

  • Electronic form. A parametric electronic questionnaire will be used with a central data repository in the statistical centre. The individual centres will access this questionnaire through a web form.
  • Classic form. A printed CRF will be used, a central digitization will be performed by trained personnel directly in the statistical centre.

Personal data protection

All patients involved in this project will be identified by an unique ID. It will be impossible to reveal the patient’s identity from this ID. The source data will be checked by the monitor. Only the examining physician or accredited healthcare professionals will be acquainted with the unique ID of a given patient.

The personal identification data collected in this project are the following: date of birth, gender and initials. The character of identifiers of personal data follows all relevant legal requirements, as confirmed by an assignee (with regard to the size of population and to the access to other data, these identification data can be considered as non-specific and the individual patients as unidentifiable).

Personal data storage and management

The data will be stored in the Oracle 9i database, on a server of the Masaryk University (Brno, Czech Republic).

Quality assurance and quality control (QA/QC)

An independent monitoring will be performed in all centres involved in the project, with the objective to check data consistency in the CRF of the project and in the source documentation. The monitor will also oversee an undesired selection of patients included in the project.

Statistical data processing

With regard to the explorative character of the project, methods of descriptive statistics will be employed, commonly used in epidemiologic studies. The primary objective of the project is the assessment of frequency of incidence of skeletal related events in a target patient population; the estimate will be accompanied by an appropriate confidence interval. The Kaplan-Meier method will be employed for the survival analysis. The statistical data processing will involve a correlation analysis of possible relations between collected data.

The final report will involve a descriptive evaluation of all monitored parameters in individual patients. A descriptive statistical analysis will respect the type of data (continuous, ordinal and binary) and the distribution of values (normal, log-normal etc.). Basic statistical parameters will be calculated (average, median, relative rate) and confidence measures in the assessment of parameters in groups of patients (SD, SE, confidence interval, percentiles).

Within the statistical processing, data from all patients included in the study will be used; no targeted selection will be performed.