Predictive Clinical and Biological Parameters in Acute Leukemia, Myelodysplastic Syndromes and Myeloproliferative Disorders-HEMATO-BIO-IPC-2013-015
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 650
- 试验地点
- 2
- 主要终点
- Acute leukemia/ Myeloproliferative/ myelodysplastic syndrome cells profiling (molecular analysis, epigenetic profile, drug sensitivity profile,immunophenotyping)
研究概览
简要总结
HEMATO-BIO-IPC-2013-015 is a monocenter prospective longitudinal study. Our aim is to define predictive clinical and biological factors in acute leukemia, myelodysplastic syndromes and myeloproliferative disorders by using genomics, genetics and epigenetics, in vitro and in vivo drug sensitivity studies,and translational immonulogy and immunomonitoring studies.
HEMATO-BIO primary outcome measure is to identify molecular, genomic and epigenetic, pharmacologic and immunophenotypic alteration in acute leukemia, myelodysplastic syndromes and myeloproliferative disorders by collecting, at diagnosis and/or complete remission and/or relapse:
- tumor samples: marrow aspiration, blood sampling.
- non-tumor samples: skin biopsy, buccal swab . from 650 patients treated at our cancer center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •acute leukemia, myelodysplastic syndrome or myeloproliferative disease
- •age > 18
- •affiliated to the French Social Security Systm
- •signed informed consent
排除标准
- •emergency
- •patients deprived of liberty or placed under the authority of a tutor
研究组 & 干预措施
Acute leukemia/myelodysplastic or myeloproliferative disease
干预措施: Blood sampling (Other)
Acute leukemia/myelodysplastic or myeloproliferative disease
干预措施: Bone marrow aspirate (Other)
Acute leukemia/myelodysplastic or myeloproliferative disease
干预措施: Skin biopsy (Other)
Acute leukemia/myelodysplastic or myeloproliferative disease
干预措施: Buccal swab (Other)
结局指标
主要结局
Acute leukemia/ Myeloproliferative/ myelodysplastic syndrome cells profiling (molecular analysis, epigenetic profile, drug sensitivity profile,immunophenotyping)
时间窗: up to 8 years
次要结局
- Compare cancer and non-tumor cells genome(up to 8 years)
- Correlation between molecular alteration and clinical characteristics(diagnosis,cytogenetics,overall survival, progression free survival)(up to 8 years)