Molecular Mechanisms of Disease Relapse After Allogenic Stem Cell Transplantation in Patients With Myelodysplastic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 38
- 试验地点
- 7
- 主要终点
- CD34+ blast cells modifications
研究概览
简要总结
This is a biological study for adult MDS patients who undergo HSCT procedure. Viable bone marrow samples will be collected and cryopreserved from MDS patients before transplantation and at clinical disease recurrence. CD34+ blast cells at disease relapse after HSCT will be compared with CD34+ cells collected before transplant to study genomic and transcriptomic changes.
详细描述
This is a biological study for adult MDS patients who undergo HSCT procedure.The research is focused on the study of biological mechanisms of disease relapse after HSCT in MDS to provide the rationale to develop pre-emptive strategies in patients with high risk of transplant failure.
Viable bone marrow samples will be collected and cryopreserved from MDS patients before transplantation and at clinical disease recurrence.
CD34+ blast cells at disease relapse after HSCT will be compared with CD34+ cells collected before transplant by using Single-cell sequencing.
To study genomic and transcriptomic changes in CD34+ blast cells at disease relapse after HSCT will be used TARGET-seq in parallel with unbiased whole-transcriptome analysis.
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
- •Diagnosis of MDS according to 2016 WHO criteria
- •Aged 18y or older
- •Patients who will receive allogeneic stem cell transplantation (HSCT)
- •Signed written informed consent according to ICH/EU/GCP and national local laws
排除标准
- •Second HSCT procedure.
结局指标
主要结局
CD34+ blast cells modifications
时间窗: at 24 months
Difference in frequency distribution of CD34+ blast cells mutations between transplant and relapse.
次要结局
未报告次要终点