EUTOS Registry Work plan

Work plan for subproject Registry

Study type

The registry collects strictly observational data only, which will be recorded retrospectively and prospectively from all kinds of healthcare settings across Europe. The predominant study design will be that of a cohort study, eventually with comparator groups (depending on the analyses, for example, we may compare the outcome or treatment of patients with low, intermediate or high risk, or compare groups with different cytogenetic characteristics at baseline).

The aim is to study the epidemiology of CML and to gain insight into the ‘real world’ treatment of patients with CML, and considerable care will be taken to provide representative samples of patients. Bearing in mind the differing healthcare systems in Europe, plans are being formulated in close collaboration with the national CML study groups, to facilitate collection of data from CML patients in routine care across Europe.

Registry population

To reduce bias, data is collected from three different groups of patients:

In-study: Patients from national study groups enrolled in prospective studies, taking imatinib frontline

• 2389 patients enrolled in on-going studies of imatinib-based regimens frontline
• Patients have been diagnosed between 2002 and 2006
• High quality and quantity of data have been collected, due to the rigorous study protocols enforced by the respective Study Groups
• Patients in this group have substantial follow-up data (4–8 years in 2010)
• ELN centers in volved in the IN study registry:

Out-study: Patients already registered in existing databases, irrespective of frontline treatment

• 1582 patients registered in already existing or planned databases of national/regional study groups or reference centers
• Patients have been diagnosed between 2002 and 2006
• Out-study patients serves as a control group for the in-study patients (the selection bias is different)
• Creation of the out-study group also allows some countries with no in-study patients to contribute to the Registry
• Patients in this group have substantial follow-up data (4–8 years in 2010)
• ELN centers in volved in the OUT study registry:

Prospective: Newly diagnosed patients not previously included in registries or clinical studies

• 836 patients newly diagnosed registered
• Study groups are covering either a whole country or a region of a country, not exceeding 10 million people (details to be negotiated with study groups or with reference centers)

Patient Eligibility

Patients must be newly diagnosed with Ph+ or BCR-ABL positive CML, and aged ≥ 18 years, to be eligible for the registry.

Core Data Set (In- and Out-Study Patients)

A core data set for ‘prospective’ group of patients has been developed. The finalized core data set for ‘in-study’ and ‘out-study’ patients is available through the ‘Documents’ section of the EUTOS for CML Registry website.

Key baseline data correspond to criteria of eligibility for including a case in the registry, and are therefore mandatory; these baseline data include essential anagraphical variables, hematologic, cytogenetic and molecular data confirming the diagnosis, the phase of the disease, and the prognostic scores. If lacking or incomplete, specific queries will be sent to the responsible investigator.

Other baseline variables as well as follow-up data are also very important but their absence should not preclude the registration of a patient, as this would introduce a selection bias into the registry. However, these ‘non-mandatory’ variables contribute greatly to improving the general quality of the information retrieved and, consequently, the quality and the scientific level of the registry. For this reason, they could be the object of specific queries.

Data Management and Quality Control

The data is collected and quality controlled by the national data collection centers and then forwarded electronically, in English, at regular intervals to the Central Data Center in Munich. There will be a variety of electronic options for forwarding the data, including internet, CD, etc. Data is checked for completeness and plausibility at the Central Data Center.

Data Confidentiality Issues and Ethics

The registry uses pseudonymized data only. Thus the identity of patients is only known by the attending physician, if not specified in a different manner by national regulations. In any case the data held at the Central Data Center in Munich is handled in strict compliance with the German law; the data collected and transferred by the various ELN participants is handled in strict compliance with the data confidentiality laws of the various member states.

The registry is strictly observational in nature, and no diagnostic or therapeutic intervention is caused by the registry.

Achievements and scope of EUTOS Extension (2011-2012)

Created by: D.Goekbuget , generated 2007/12/19 , last changed: 2011/06/14