Sequential Analysis in Patients With an Hemopathy
试验速览
- 阶段
- 不适用
- 入组人数
- 246
- 试验地点
- 1
- 主要终点
- Identification of new genetic alterations
研究概览
简要总结
Recent advances in hematology clearly illustrate that the simple "clonal" nature of various hematological malignancies may not really reflect the reality of malignant cells natural expansion. This has been nicely illustrated in recent works in AML for example where subclones coexists in the same patient at the same time, but could also differentially expand over time because of effects of therapeutics intervention, but also by oncogenic spontaneous events (1).
These observations have been done recently because of next generation sequencing that allows to discriminate in the same tumor samples, different subclones and to analyse the clonal architecture. Sequential analyses could help us to identify the first oncogenic event and to correlate disease progression to the emergence of subclones.
For all these reasons it is of a major interest to precisely understand the architecture of the clone in MPNs, especially to understand which is the initiating event and how from this initial event the clone develops.
In MPNs in which JAK2V617F is the initiating event, its targeting is expected to be extremely effective. If JAK2V617F is a secondary event its targeting might allow to alleviate the MPN, but may favor the development of other malignant hemopathies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patients with a malignant hematological disease.
- •Signed written informed consent
- •Age and Sex : men and women aged 18 years or older
- •Patients affiliated to a social security system
排除标准
- •- Patients protected by law, in accordance with Articles L1121-L1121-5 to 8 of the Code of Public Health.
研究组 & 干预措施
chronic myelomonocytic leukemia
Three cohorts will be investigated: ET (essential thrombocythemia), IMF and secondary MF (myelofibrosis) and CMML (chronic myelomonocytic leukemia)
干预措施: Blood samples (Other)
essential thrombocytemia
Three cohorts will be investigated: ET (essential thrombocythemia), IMF and secondary MF (myelofibrosis) and CMML (chronic myelomonocytic leukemia)
干预措施: Blood samples (Other)
myelofibrosis
Three cohorts will be investigated: ET (essential thrombocythemia), IMF and secondary MF (myelofibrosis) and CMML (chronic myelomonocytic leukemia)
干预措施: Blood samples (Other)
结局指标
主要结局
Identification of new genetic alterations
时间窗: At baseline and then every 6 months up to 24 months
Identification of new genetic alterations in patients with hematological malignancies by next generation sequencing using blood samples
次要结局
- Sequential analysis of the malignant clones(At baseline and 12 months after inclusion)
