Registry of Myelodysplastic Syndromes and Therapy-related Acute Myeloid Leukemia

The Registry MDS is an ongoing, observational study that has collected longitudinal data on diagnostics, demographics, clinical parameters, and health Care Interventions (HCI) from patients with MDS and therapy-related acute myeloid leukemia.

This registry was created in July 2003 by GFM Group. It is conducted in accordance with the French law on data processing and freedom relating to the processing of personal data in the field of health (law n°78-17 of 6 January 1978 as amended). It has received the favorable opinion of the ethics committee for research and the authorization of the National Commission on Informatics and Freedoms. (CNIL) Included in the registry are all patients over 18 years of age with MDS or secondary chemo- and/or radio-induced leukemia diagnosed after July 2003.

The registry allows, after obtaining the patient's consent, the anonymous recording of his or her demographic (sex, age), epidemiological (medical and family history, exposure to toxicants), clinical, biological, cytological and cytogenetic data. Included in the registry are all patients over 18 years of age with MDS or secondary chemo- and/or radio-induced leukemia diagnosed after July 2003.

The registry allows, after obtaining the patient's consent, the anonymous recording of his or her demographic (sex, age), epidemiological (medical and family history, exposure to toxicants), clinical, biological, cytological and cytogenetic data.

To date, 70 GFM centers participate in this registry, 5300 patients have been included. Approximately 400 to 500 new patients are currently included per year.

Data are recorded and entered through the web-based e-CRF by haematology centers in 70 centers of GFM at inclusion and Follow-up of the patients every six months.

Data analyses are conducted by the SBIM (Medical and Biostatistical Computing at service of Pr Sylvie CHEVRET, Hospital Saint Louis). Data quality control including monitoring of both clinical execution and data collection implemented from the initiation of the Registry has resulted in high quality data.

Registry MDS has included the most patients and has proven itself as a well-established operational, and constantly evolving project in an elderly population.

The registration of new patients is still ongoing, and the follow-up of the project is unlimited.

• Overall survival [Срок оценки: From diagnosis until death or last follow-up, up to 120 months]
• Progression-free survival [Срок оценки: From diagnosis until progression, AML transformation, or death, assessed up to 120 months]
• Incidence of bone marrow failure events (anemia, neutropenia, thrombocytopenia) [Срок оценки: From diagnosis until last follow-up, up to 120 months]
• Duration of first-line treatment for MDS [Срок оценки: From treatment initiation until discontinuation or last follow-up, assessed up to 60 months]
• Time to first documented treatment response [Срок оценки: From treatment start to first response, assessed up to 60 months]
• Time to transformation to acute myeloid leukemia (AML) [Срок оценки: From diagnosis until AML confirmation or last follow-up, up to 120 months]
• Time to transfusion dependency [Срок оценки: From diagnosis to transfusion dependency or last follow-up, up to 120 months]
• Cytogenetic and molecular response rates [Срок оценки: Assessed during follow-up, up to 120 months]
• Time to progression on IPSS score [Срок оценки: From initial classification to IPSS progression or last follow-up, up to 120 months]