The Clermont-Ferrand University Hospital leads the CML Observatory, a national real-world data registry dedicated to chronic myeloid leukemia (CML). This initiative aims to centralize clinical and biological data from patients monitored for CML, in order to advance research and improve the quality of care in France.
Under the medical responsibility of Professor Marc Berger, the initiative is jointly supported by the Biological Hematology, Adult Clinical Hematology, and Cell Therapy departments at CHU Estaing. The IT infrastructure is managed in partnership with the Montpellier University Hospital (Mr. Dalil Hamroun) and benefits from the support of the academic Fi-LMC group, which brings together French experts on the disease.
The Biological Hematology department plays a central role in coordinating the CML Observatory, with a long-standing approach of making the database available to centers that wish to participate, in order to build the largest possible real-world data cohort. The team designed the Observatory in line with international recommendations and can adapt it, together with the database IT engineer, as new knowledge about CML emerges. After obtaining the patient’s informed consent, clinico-biological data from diagnosis, follow-up—including analysis of therapeutic responses and any intolerance to targeted therapies—are recorded by each participating center. The CML Observatory requires close collaboration between physicians, biologists, data managers, and researchers to enable effective clinical and translational research.
The Biological Hematology team also ensures the verification and validation of biological data integrated into the CML Observatory, guaranteeing their reliability and scientific quality. It organizes regular monitoring of participating centers.
By combining advanced technological tools, a high-level hospital-university environment, and a strong commitment to collaborative research, the Biological Hematology department fully contributes to improving knowledge of this disease and optimizing patient care nationwide.
Today, more than 20 hospitals and cancer centers across the country contribute to this observatory, making it the largest French cohort of patients with CML, already bringing together over 1,800 patients.
A secure database, a collective commitment
Patient participation is voluntary and governed by an informed consent process. The data, collected in a non-identifiable manner, comply with current regulatory standards, including GDPR. They are hosted in a secure environment (MIPIH), and the Observatory is currently transitioning to a health data warehouse (EDS) compliant with CNIL guidelines.
This collaborative organization makes it possible to:
- Build a solid foundation for real-world studies;
- Better understand rare forms of the disease;
- Analyze the long-term effects of treatments;
- Monitor the evolution of therapeutic practices across the country.
Concrete results serving research
Since its creation in 2013, the CML Observatory has already enabled significant progress. Two major publications have been released:
- 2022: Study on therapeutic response to tyrosine kinase inhibitors and treatment discontinuations in real-world settings (Annals of Hematology).
- 2024: Identification of early predictive criteria for treatment response (Haematologica).
Publications from the Observatory are available via the transparency portal of the Clermont-Ferrand University Hospital.
A continuous research momentum
Several scientific projects are currently under analysis, with the ambition of publishing innovative results every year. These studies aim to refine therapeutic strategies and promote personalized medicine for patients with CML.
A collective commitment to serving patients
This project could not exist without the commitment of patients, healthcare professionals, clinical research associates, legal experts, and dedicated IT specialists. Data analysis relies on biostatistics experts. The Clermont-Ferrand University Hospital extends its sincere thanks to all the stakeholders involved in this key program for Onco-Hematology.
