基于液体活检的胰腺癌 cfDNA 甲基化和蛋白质生物标志物的鉴定和验证模型（DAYBREAK 研究）
2022年8月9日 更新者：Guo ShiWei、Changhai Hospital
通过外周血液体活检检测胰腺癌：一项前瞻性研究
DAYBREAK 是一项前瞻性、多组学、观察性研究，旨在通过联合检测 cfDNA 甲基化、血清蛋白标志物、血液 miRNA 标志物等生物标志物来早期检测胰腺癌，将招募 450 名参与者。
该模型的开发和验证将通过两阶段方法在患有早期癌症和良性疾病的参与者中进行。
将评估该模型在胰腺癌早期检测中的敏感性和特异性。
研究概览
地位
招聘中
条件
研究类型
观察性的
注册 (预期的)
450
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：Shiwei Guo, M.D.
- 电话号码：18621500666
- 邮箱：gestwa@163.com
研究联系人备份
- 姓名：Yuzi Zhang, M.D.
- 电话号码：+86-021-60293798
- 邮箱：Z_Zhangyuzi@163.com
学习地点
-
-
Shanghai
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Shanghai、Shanghai、中国、200433
- 招聘中
- Shanghai Changhai Hospital
-
接触：
- Shiwei Guo, M.D.
- 电话号码：18621500666
- 邮箱：gestwa@163.com
-
-
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
40年 至 75年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
符合条件的参与者将从医疗中心招募并分配到两组，包括新诊断为恶性肿瘤或相应良性疾病的参与者。
描述
癌症手臂参与者的纳入标准：
- 能够提供书面知情同意书。
- 能够为研究测试提供充足且合格的血液样本。
- 未接受或接受过以下任一癌症治疗（局部或系统性）：
- A. 研究抽血前 42 天内经病理学证实的癌症诊断。
- B. 通过放射学或其他常规临床评估高度怀疑癌症诊断，并在研究抽血后 42 天内通过活组织检查或手术切除确诊癌症。
癌症手臂参与者的排除标准：
- 用于研究测试的合格血液样本不足。
- 在怀孕或哺乳期间。
- 器官移植或先前非自体（同种异体）骨髓或干细胞移植的接受者。
- 在研究抽血前 30 天内接受过输血。
- 合并其他已知的恶性肿瘤或多原发肿瘤。
良性疾病组参与者的纳入标准：
- 能够提供书面知情同意书。
- 能够为研究测试提供充足且合格的血液样本。
- 有以下任一情况：
- A. 研究抽血前 90 天内经病理证实诊断为良性疾病，且未进行手术切除等既往治疗。
- B. 高度怀疑通过放射学或其他常规临床评估诊断良性疾病，并在研究抽血后 42 天内确诊良性疾病诊断。
良性疾病组参与者的排除标准：
- 用于研究测试的合格血液样本不足。
- 在怀孕或哺乳期间。
- 器官移植或先前非自体（同种异体）骨髓或干细胞移植的接受者。
- 在研究抽血前 30 天内接受过输血。
- 由于癌症以外的疾病，在研究抽血前 30 天内接受过任何抗癌治疗
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
队列和干预
团体/队列 |
|---|
|
癌症手臂
新诊断出胰腺癌的参与者，将从他们那里采集血样。
|
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良性疾病手臂
患有良性胰腺疾病的参与者，将从中采集血样。
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
联合模型在癌症组和良性疾病组中早期检测多癌的敏感性和特异性
大体时间：12个月
|
12个月
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
不同临床阶段胰腺癌参与者的敏感性和特异性差异。
大体时间：12个月
|
12个月
|
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基于 cfDNA 甲基化的模型与其他生物标志物相结合检测胰腺癌的灵敏度和特异性。
大体时间：12个月
|
12个月
|
|
基于蛋白质面板的模型与其他生物标志物相结合检测胰腺癌的灵敏度和特异性。
大体时间：12个月
|
12个月
|
|
基于血液 miRNA 的模型在检测胰腺癌中的敏感性和特异性。
大体时间：12个月
|
12个月
|
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。
调查人员
- 学习椅：Gang Jin, M.D.、Department of general surgery, Changhai Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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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)
2022年3月24日
初级完成 (预期的)
2023年12月31日
研究完成 (预期的)
2024年6月30日
研究注册日期
首次提交
2022年8月9日
首先提交符合 QC 标准的
2022年8月9日
首次发布 (实际的)
2022年8月10日
研究记录更新
最后更新发布 (实际的)
2022年8月10日
上次提交的符合 QC 标准的更新
2022年8月9日
最后验证
2022年8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.