Risk Stratification Value of Deep NGS-MRD Detection in Acute Myeloid Leukemia Patients After Allo-HSCT
Risk Stratification Value of Deep NGS-MRD Detection in Acute Myeloid Leukemia Patients After Hematopoietic Stem Cell Transplantation
To assess the value of deep NGS-MRD detection for risk stratification in adult high-risk acute myeloid leukemia (AML) patients, in this prospective, single-center, observational cohort study following allogeneic hematopoietic stem cell transplantation (allo-HSCT). A total of 169 patients will be enrolled, and deep NGS-MRD testing will be performed at approximately +3 months after transplantation. Patients will be stratified into NGS-MRD-positive and NGS-MRD-negative groups based on test results. No investigational interventions will be administered. Follow-up analyses will evaluate the associations between NGS-MRD status and post-transplant relapse and survival.
研究概览
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Erlie Jiang
- 电话号码:+86-15122538106
- 邮箱:jiangerlie@ihcams.ac.cn
研究联系人备份
- 姓名:Dan Feng
- 电话号码:+86-17863810313
- 邮箱:fengdan@ihcams.ac.cn
学习地点
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Tianjin Municipality
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Tianjin、Tianjin Municipality、中国、300020
- National Clinical Research Center for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
To assess the risk-stratifying value of deep NGS-MRD detection in high-risk acute myeloid leukemia (AML) patients following allogeneic hematopoietic stem cell transplantation (allo-HSCT), this prospective, single-center, observational cohort study plans to enroll 169 patients. Deep NGS-MRD testing will be performed at approximately +3 months after transplantation.
描述
Inclusion Criteria:
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Age ≥ 18 years;
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Diagnosis as high-risk AML meeting at least one of the following criteria:
- Adverse group according to the 2022 ELN risk classification;
- Failure to achieve molecular remission or MRD positivity before transplantation;
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Receipt of allogeneic hematopoietic stem cell transplantation (allo-HSCT);
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KPS score ≥ 60;
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Written informed consent obtained from the patient or legal guardian
Exclusion Criteria:
- Presence of morphological, flow cytometric, or molecular evidence of relapse at +3 months after transplantation;
- Concurrent diagnosis of another malignant neoplasm;
- Poor follow-up compliance or inability to complete NGS testing;
- Other conditions for which the investigator deems the subject ineligible to participate in this trial.
学习计划
研究是如何设计的?
设计细节
- 观测模型:COHORT
- 时间观点:PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
NGS-MRD AML cohort
This prospective, single-center, observational cohort study plans to enroll 169 high-risk acute myeloid leukemia (AML) patients receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT). Deep NGS-MRD testing will be conducted at approximately +3 months after transplantation. |
Deep NGS-MRD testing will be conducted at approximately +3 months after transplantation. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
6-month cumulative incidence of relapse
大体时间:6 months after transplantation
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Calculated from the date of the +3-month NGS-MRD assay until the first occurrence of AML relapse. |
6 months after transplantation
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
1 year cumulative incidence of relapse
大体时间:1 year after transplantation
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Calculated from the date of transplantation until the first occurrence of AML relapse. |
1 year after transplantation
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2 year cumulative incidence of relapse
大体时间:2 year after transplantation
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Calculated from the date of transplantation until the first occurrence of AML relapse. |
2 year after transplantation
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Relapse free survival
大体时间:2 year after transplantation
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Calculated from the date of transplantation until the relapse or death |
2 year after transplantation
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Overall survival
大体时间:2 year after transplantation
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Calculated from the date of transplantation until death |
2 year after transplantation
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Non-relapse mortality
大体时间:2 year after transplantation
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Calculated from the date of transplantation until death without relapse |
2 year after transplantation
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Time interval from NGS-MRD positivity to clinical relapse
大体时间:2 year after transplantation
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3-months NGS-MRD positivity to clinical relapse |
2 year after transplantation
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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