An observational study in Myelodysplastic Syndromes and Leukemia, Myeloid, Acute, sponsored by Groupe Francophone des Myelodysplasies. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Groupe Francophone des Myelodysplasies · Observational
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
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.
Included in the "Registry" are all patients over 18 years of age with myelodysplastic syndrome and therapy-related acute myeloid leukemia
Exclusion Criteria:
Hemoglobin level Unit of Measure g/dL
Hemoglobin concentration in patients at the time of inclusion.
Time frame: At enrollment
Absolute neutrophil count / Unit of Measure G/L
Neutrophil count measured at baseline
Time frame: At enrollment
Platelet count Unit of Measure / Unit of Measure: %G/L
Neutrophil count measured at baseline
Time frame: At enrollment
Percentage of bone marrow blasts at enrollment / Unit of Measure: percent
Proportion of blasts in bone marrow aspirate
Time frame: At enrollment
Presence of multilineage dysplasia at enrollment / Unit of Measure percent of patients
Number and proportion of patients with multilineage dysplasia
Time frame: At enrollment
Cytogenetic abnormalities at enrollment / Unit of Measure percent of patients
Distribution of cytogenetic profiles observed in patients (e.g., normal karyotype, del(5q), complex karyotype, etc.).
Time frame: At enrollment
IPSS-R risk classification at enrollment / Unit of Measure percent of patients by category
Number and proportion of patients in each IPSS-R risk category.
Time frame: At enrollment
Presence of somatic mutations at enrollment / Unit of Measure: percent of patients
o Description: Frequency of key somatic mutations (e.g., SF3B1, TP53, ASXL1, etc.) identified in included patients
Time frame: At enrollment
Demographic characteristics at enrollment / Unit of Measure: Descriptive (e.g., mean ± SD for age, % for sex distribution)
Distribution of age, sex, and other demographic parameters among included patients
Time frame: At enrollment
Overall survival
Time from diagnosis to death from any cause or last follow-up Progression-free survival Bone marrow failure (anemia, neutropenia and thrombocytopenia) Treatment duration and time response Time to IPSS progression, Rate and time to AML evolution Time-to-transfusion dependency Cytogenetic and molecular response
Time frame: From diagnosis until death or last follow-up, up to 120 months
Progression-free survival
Time from diagnosis to progression to higher-risk MDS, transformation to AML, or death from any cause
Time frame: From diagnosis until progression, AML transformation, or death, assessed up to 120 months
Incidence of bone marrow failure events (anemia, neutropenia, thrombocytopenia)
Number of patients presenting with hemoglobin \<10 g/dL, neutrophils \<1.0 G/L, or platelets \<100 G/L during follow-up.
Time frame: From diagnosis until last follow-up, up to 120 months
Duration of first-line treatment for MDS
Time from initiation to discontinuation of the first-line therapeutic regimen
Time frame: From treatment initiation until discontinuation or last follow-up, assessed up to 60 months
Time to first documented treatment response
Time from treatment initiation to the first response according to IWG-MDS 2006 criteria.
Time frame: From treatment start to first response, assessed up to 60 months
Time to transformation to acute myeloid leukemia (AML)
Time from MDS diagnosis to confirmed AML transformation (≥20% blasts in bone marrow).
Time frame: From diagnosis until AML confirmation or last follow-up, up to 120 months
Time to transfusion dependency
Time from diagnosis to the need for regular transfusions, defined as ≥2 units/month for ≥2 consecutive months.
Time frame: From diagnosis to transfusion dependency or last follow-up, up to 120 months
Cytogenetic and molecular response rates
Number and proportion of patients achieving partial or complete cytogenetic and/or molecular responses during follow-up.evaluations.
Time frame: Assessed during follow-up, up to 120 months
Time to progression on IPSS score
Time from initial IPSS classification (very low/low) to high or very high-risk category.
Time frame: From initial classification to IPSS progression or last follow-up, up to 120 months
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Groupe Francophone des Myelodysplasies