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CLLEAR
The CLLEAR registry comprises comprehensive data on patients with chronic lymphocytic leukemia, which are structured into several chapters. A range of predefined variables are collected at the time of significant events: diagnosis, treatment, relapse/progression, transplantation or death. There are detailed data regarding baseline demographic characteristics, epidemiology, prognostic markers, cytogenetics and molecular genetic characteristics of CLL, biochemical markers, CIRS score, blood count and bone marrow findings, treatment regimens eventually including hematopoietic stem cells transplantation, as well as comorbidities, secondary malignancies and other data according requirements.
General information
Primary purpose and goals of the CLLEAR registry are collection of epidemiological and clinical data on CLL patients, evaluation of treatment outcomes and contribution to betterawareness of achieved treatment outcomes.
Secondarily, the CLLEAR registry can provide source data for research purposes. These data can be merged with research analyses of patients ́ blood samples to evaluate role of novel prognostic and predictive markers, clonal evolution or novel treatment approaches in CLL.The overall purpose of the registry is to assure high quality patient care and diagnostics for CLL patients in the Czech Republic.
Signed ICF
Confirmed diagnosis
Non-compliance with inclusion criteria
Manual data entry by trained datamanagers in the involved centres
All programmed validations are being performed in different steps of data entry process. During the dataprocessing, in the first step the format of all variables, whether variable is mandatory and programmed coherence checks on the form level are checked. Registry user can interact immediately by correcting the value inserted or leave it be for later correction (Pending form state would then be used as it allows invalid data).
The next step of data validation process are programmed coherence checks that validate parameters across the whole database. Based on used EDC system and setup of concrete project, results of these checks might lead to generation of queries in order to correct data. Queries can also be set to allow user input. Investigator can then respond to those queries and for example clarify a rare case with specific parameters combination for which those validations should be manually overridden. Project coordinator, monitor or data manager can then reply as well or communicate the case further in details. The whole communication is attached to that specific query.
The individual treatment lines are recorded as partial therapeutic forms. An overview of the treatment is given on the monitoring form.