Biomarkers in Bone Marrow Supernatant for Predicting AML Chemosensitivity
2026年5月8日 更新者:Fujian Medical University Union Hospital
Bone Marrow Microenvironment Signatures for Predicting AML Prognosis and Resistance
Chemoresistance in acute myeloid leukemia (AML) is closely associated with the bone marrow microenvironment.
Elevated levels of IL-6, leptin, fumarate, and other factors within the bone marrow microenvironment have been shown to enhance oxidative phosphorylation or antioxidant capacity in AML cells, thereby inducing chemoresistance.
To explore their potential as prognostic biomarkers or therapeutic targets, this study plans to enroll 405 newly diagnosed AML patients meeting the criteria of the Chinese Guidelines for the Diagnosis and Treatment of Adult Acute Myeloid Leukemia (2023 Edition), along with 81 sex- and age-matched healthy controls.
By analyzing the levels of IL-6, leptin, fumarate, and other factors in patient bone marrow supernatant, we will evaluate their associations with treatment response (primary endpoints: overall survival [OS] and overall response rate [ORR] after one cycle of chemotherapy) and prognosis.
Furthermore, patient-derived xenograft (PDX) mouse models established from primary AML cells will be used to validate their roles in chemoresistance, aiming to provide a basis for therapies targeting the bone marrow microenvironment.
研究概览
研究类型
观察性的
注册 (估计的)
405
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Huifang Huang
- 电话号码:0591-86218641 13365910318
- 邮箱:huanghuif@fjmu.edu.cn
学习地点
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Fujian
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Fuzhou、Fujian、中国
- 招聘中
- Fujian Medical University Union Hospital
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接触:
- Huifang Huang
- 电话号码:0591-86218641 13365910318
- 邮箱:huanghuif@fjmu.edu.cn
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-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
取样方法
非概率样本
研究人群
This prospective study enrolls patients who fulfill the diagnostic criteria for AML(excluding APL), with an age requirement of over 18 years and no restrictions on gender.
Participation is entirely voluntary, with each participant or their legal guardian being thoroughly informed about the study details and signing an informed consent form.
Participants are willing to adhere to and capable of completing all required study procedures.
描述
Inclusion Criteria:
- Clinical diagnosis aligns with the "Chinese guidelines for diagnosis and treatment of adult acute myeloid leukemia (not APL) (2023)";
- All patients are experiencing their first onset of the disease and have not received any related chemotherapy prior to the study;
- Patients participate in the study accompanied by family members and sign informed consent documents.
Exclusion Criteria:
- Patients with concurrent malignancies requiring treatment;
- Presence of infectious diseases, including SARS, viral hepatitis, or HIV/ AIDS;
- Major surgery performed within the last 21 days;
- Performance Status (PS) score >3;
- Severe liver or kidney dysfunction or serious infection;
- Severe psychiatric conditions that impair understanding of the study protocol or voluntary withdrawal.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
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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ORR
大体时间:The first month after the first chemotherapy
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The primary endpoint of this study is the overall response rate (ORR) after Chemotherapy
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The first month after the first chemotherapy
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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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CR
大体时间:The first month after the first chemotherapy
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The secondary endpoints is the complete remission (CR) rate after Chemotherapy
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The first month after the first chemotherapy
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CRi
大体时间:The first month after the first chemotherapy
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The secondary endpoints is the complete remission with incomplete blood count recovery (CRi) rate after Chemotherapy
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The first month after the first chemotherapy
|
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PR
大体时间:The first month after the first chemotherapy
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The secondary endpoints is the partial remission (PR) rate after Chemotherapy
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The first month after the first chemotherapy
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OS
大体时间:3 year
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The secondary endpoints is the overall survival (OS)
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3 year
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年12月1日
初级完成 (估计的)
2027年12月31日
研究完成 (估计的)
2030年1月1日
研究注册日期
首次提交
2026年5月8日
首先提交符合 QC 标准的
2026年5月8日
首次发布 (实际的)
2026年5月14日
研究记录更新
最后更新发布 (实际的)
2026年5月14日
上次提交的符合 QC 标准的更新
2026年5月8日
最后验证
2025年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.