Immune Reconstitution and Clinical Prognosis Following Umbilical Cord Blood Transplantation
A Prospective Study on Immune Reconstitution and Clinical Prognosis in Patients After Umbilical Cord Blood Transplantation
In this prospective randomized controlled trial of umbilical cord blood hematopoietic stem cell transplant recipients, post-transplant immune data will be collected from two groups. A composite immune risk score will be used to assess immune reconstitution for risk stratification and analyze its associations with clinical prognostic endpoints.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Yahui Feng
- 电话号码：022-23608045
- 邮箱：fengyahui@ihcams.ac.cn
学习地点
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Tianjin、中国
- 招聘中
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
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接触：
- Yahui Feng
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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
描述
Inclusion Criteria:
- Age ≥ 14 years old
- Umbilical cord blood transplant
- Patients must provide written informed consent before the start of the study procedures.
Exclusion Criteria:
- Patients who are ineligible for the study due to other factors, or who will bear great risk if they participate in the study.
- Death or loss to follow-up of the patient prior to immune reconstitution stratification
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Composite Immune Risk Score Stratification Notification Group
Attending physicians will receive immune reconstitution risk stratification results of patients calculated by the composite immune risk score model to guide patient health monitoring. |
Attending physicians will receive immune reconstitution risk stratification results of patients calculated by the composite immune risk score model to guide patient health monitoring. |
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无干预：Standard Care Control Group
No risk stratification results of patients from the composite immune risk score model will be provided to attending physicians. Patients receive standard routine care. |
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 |
|---|---|---|
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Frequency of infection-related laboratory testing (blood culture, pathogen PCR, NGS)
大体时间：6 months post-transplant
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Defined as the count of infection-related laboratory tests (blood culture, pathogen PCR, pathogen NGS) for each patient within 6 months after umbilical cord blood transplantation. Test counts are extracted from electronic medical records. |
6 months post-transplant
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Number of medication adjustments intended to accelerate immune reconstitution or enhance infection prophylaxis
大体时间：6 months post-transplant
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6 months post-transplant
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Number of return visits
大体时间：6 months post-transplant
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6 months post-transplant
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Frequency of infection-related laboratory testing (blood culture, pathogen PCR, NGS)
大体时间：1 year post-transplant
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Defined as the count of infection-related laboratory tests (blood culture, pathogen PCR, pathogen NGS) for each patient within 1 year after umbilical cord blood transplantation. Test counts are extracted from electronic medical records. |
1 year post-transplant
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Number of medication adjustments intended to accelerate immune reconstitution or enhance infection prophylaxis
大体时间：1 year post-transplant
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1 year post-transplant
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Number of return visits
大体时间：1 year post-transplant
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1 year post-transplant
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Immune reconstitution status (quantity of T, B, NK cells and other immune subsets, and T cell clonal diversity)
大体时间：at 4, 6, 9 and 12 months post-transplant
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Defined as the quantity of T cells, B cells, NK cells and other immune subsets measured by flow cytometry, and T cell clonal diversity assessed by TCR repertoire sequencing at scheduled time points. Data are extracted from electronic medical records. |
at 4, 6, 9 and 12 months post-transplant
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Infection rate
大体时间：at 6, 9 and 12 months post-transplant
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at 6, 9 and 12 months post-transplant
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Incidence of chronic GVHD
大体时间：at 6, 9 and 12 months post-transplant
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at 6, 9 and 12 months post-transplant
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Relapse rate
大体时间：at 6, 9 and 12 months post-transplant
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at 6, 9 and 12 months post-transplant
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Survival
大体时间：at 6, 9 and 12 months post-transplant
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at 6, 9 and 12 months post-transplant
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Hospitalization rate
大体时间：at 6, 9 and 12 months post-transplant
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at 6, 9 and 12 months post-transplant
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Outpatient rate
大体时间：at 6, 9 and 12 months post-transplant
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at 6, 9 and 12 months post-transplant
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
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
与本研究相关的术语
其他研究编号
- SKIRT-CB-RCT-001
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