Registry of Myelodysplastic Syndromes and Therapy-related Acute Myeloid Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6,990
- 试验地点
- 2
- 主要终点
- Hemoglobin level Unit of Measure g/dL
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Age > 18 years
- •Patients with myelodysplastic syndrome and therapy-related acute myeloid leukemia
- •Able and willing to provide written informed consent
排除标准
- •Age <18 years
- •Patient is unwilling or unable to give consent
结局指标
主要结局
Hemoglobin level Unit of Measure g/dL
时间窗: At enrollment
Hemoglobin concentration in patients at the time of inclusion.
Absolute neutrophil count / Unit of Measure G/L
时间窗: At enrollment
Neutrophil count measured at baseline
Platelet count Unit of Measure / Unit of Measure: %G/L
时间窗: At enrollment
Neutrophil count measured at baseline
Percentage of bone marrow blasts at enrollment / Unit of Measure: percent
时间窗: At enrollment
Proportion of blasts in bone marrow aspirate
Presence of multilineage dysplasia at enrollment / Unit of Measure percent of patients
时间窗: At enrollment
Number and proportion of patients with multilineage dysplasia
Cytogenetic abnormalities at enrollment / Unit of Measure percent of patients
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: At enrollment
Distribution of age, sex, and other demographic parameters among included patients
次要结局
- Overall survival(From diagnosis until death or last follow-up, up to 120 months)
- Progression-free survival(From diagnosis until progression, AML transformation, or death, assessed up to 120 months)
- Incidence of bone marrow failure events (anemia, neutropenia, thrombocytopenia)(From diagnosis until last follow-up, up to 120 months)
- Duration of first-line treatment for MDS(From treatment initiation until discontinuation or last follow-up, assessed up to 60 months)
- Time to first documented treatment response(From treatment start to first response, assessed up to 60 months)
- Time to transformation to acute myeloid leukemia (AML)(From diagnosis until AML confirmation or last follow-up, up to 120 months)
- Time to transfusion dependency(From diagnosis to transfusion dependency or last follow-up, up to 120 months)
- Cytogenetic and molecular response rates(Assessed during follow-up, up to 120 months)
- Time to progression on IPSS score(From initial classification to IPSS progression or last follow-up, up to 120 months)