Registry of Myelodysplastic Syndromes and Therapy-related Acute Myeloid Leukemia

Condition(s) studied

Study summary

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

Eligibility

Primary outcome measure(s)

• Hemoglobin level Unit of Measure g/dL — At enrollment
  Hemoglobin concentration in patients at the time of inclusion.
• Absolute neutrophil count / Unit of Measure G/L — At enrollment
  Neutrophil count measured at baseline
• Platelet count Unit of Measure / Unit of Measure: %G/L — At enrollment
  Neutrophil count measured at baseline
• Percentage of bone marrow blasts at enrollment / Unit of Measure: percent — At enrollment
  Proportion of blasts in bone marrow aspirate
• Presence of multilineage dysplasia at enrollment / Unit of Measure percent of patients — At enrollment
  Number and proportion of patients with multilineage dysplasia
• Cytogenetic abnormalities at enrollment / Unit of Measure percent of patients — At enrollment
  Distribution of cytogenetic profiles observed in patients (e.g., normal karyotype, del(5q), complex karyotype, etc.).
• IPSS-R risk classification at enrollment / Unit of Measure percent of patients by category — At enrollment
  Number and proportion of patients in each IPSS-R risk category.
• Presence of somatic mutations at enrollment / Unit of Measure: percent of patients — At enrollment
  o Description: Frequency of key somatic mutations (e.g., SF3B1, TP53, ASXL1, etc.) identified in included patients
• Demographic characteristics at enrollment / Unit of Measure: Descriptive (e.g., mean ± SD for age, % for sex distribution) — At enrollment
  Distribution of age, sex, and other demographic parameters among included patients

Trial sites (1)

More Groupe Francophone des Myelodysplasies trials in France

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