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注册号: Registration number: |
ChiCTR2600120581 |
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最近更新日期: Date of Last Refreshed on: |
2026-03-17 09:47:23 |
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注册时间: Date of Registration: |
2026-03-17 00:00:00 |
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注册号状态: |
预注册 |
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Registration Status: |
Prospective registration |
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注册题目: |
机器学习结合多组学探索胰腺导管癌转移进展机制及能谱CT检测标志物的开发应用 |
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Public title: |
Machine learning combined with multi-omics to explore the mechanism of pancreatic ductal carcinoma metastasis and the development and application of spectral CT markers |
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注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
机器学习结合多组学探索胰腺导管癌转移进展机制及能谱CT检测标志物的开发应用 |
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Scientific title: |
Machine learning combined with multi-omics to explore the mechanism of pancreatic ductal carcinoma metastasis and the development and application of spectral CT markers |
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研究课题代号(代码): Study subject ID: |
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在二级注册机构或其它机构的注册号: The registration number of the Partner Registry or other register: |
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申请注册联系人: |
明帅 |
研究负责人: |
韦炜 |
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Applicant: |
Ming Shuai |
Study leader: |
Wei Wei |
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申请注册联系人电话: Applicant telephone: |
+86 159 5521 9030 |
研究负责人电话:
Study leader's |
+86 138 5600 5207 |
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申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
ming.ys@mail.ustc.edu.cn |
研究负责人电子邮件: Study leader's E-mail: |
weiweill@ustc.edu.cn |
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申请单位网址(自愿提供): Applicant website(voluntary supply): |
研究负责人网址(自愿提供): Study leader's website(voluntary supply): |
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申请注册联系人通讯地址: |
安徽省合肥市庐阳区庐江路17号 |
研究负责人通讯地址: |
安徽省合肥市庐阳区庐江路17号 |
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Applicant address: |
No.17 Lushan Road, Lujiang District, Hefei, Anhui Province |
Study leader's address: |
No.17 Lushan Road, Lujiang District, Hefei, Anhui Province |
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申请注册联系人邮政编码: Applicant postcode: |
230001 |
研究负责人邮政编码: Study leader's postcode: |
230001 |
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申请人所在单位: |
安徽省立医院 |
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Applicant's institution: |
Anhui Province Hospital |
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研究负责人所在单位: |
中国科学技术大学附属第一医院 |
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Affiliation of the Leader: |
The First Affiliated Hospital of University of Science and Technology of China |
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是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
2025KY 伦审第464号 |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
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批准本研究的伦理委员会名称: |
中国科学技术大学附属第一医院医学研究伦理委员会 |
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Name of the ethic committee: |
Medical Research Ethics Committee of the First Affiliated Hospital of University of Science and Technology of China |
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伦理委员会批准日期: Date of approved by ethic committee: |
2025-09-25 00:00:00 | ||
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伦理委员会联系人: |
胡怡然 |
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Contact Name of the ethic committee: |
Hu Yiran |
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伦理委员会联系地址: |
安徽省合肥市庐阳区庐江路17号 |
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Contact Address of the ethic committee: |
No.17 Lushan Road, Lujiang District, Hefei, Anhui Province |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 180 0969 6155 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
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研究实施负责(组长)单位: |
中国科学技术大学附属第一医院 |
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Primary sponsor: |
The First Affiliated Hospital of University of Science and Technology of China |
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研究实施负责(组长)单位地址: |
安徽省合肥市庐阳区庐江路17号 |
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Primary sponsor's address: |
No.17 Lushan Road, Lujiang District, Hefei, Anhui Province |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
国家自然科学基金面上项目,基于CT影像组学的胰腺癌肝转移风险预测及其生物学机制研究(82271991) |
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Source(s) of funding: |
National Natural Science Foundation of China General Program, Risk Prediction of Pancreatic Cancer Liver Metastasis Based on CT Imagingomics and Its Biological Mechanism (82271991) |
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研究疾病: |
胰腺导管腺癌 |
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Target disease: |
Pancreatic ductal adenocarcinoma |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
观察性研究 |
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Study type: |
Observational study |
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研究所处阶段: |
其它 | ||||||||||||||||||||||
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Study phase: |
N/A |
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研究设计: |
病例对照研究 |
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Study design: |
Case-Control study |
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研究目的: |
1. 主要目的:结合代谢组学测序数据分析PDAC转移相关能谱CT影像学检测分子代谢标志物;展示胰腺癌的能谱CT特征与肿瘤分型的关联性。 2. 次要目的:结合空间代谢组学测序,明确肿瘤转移相关代谢物的表达水平;进行临床PDAC相关分子诊断的细胞标记物及分子标志物。 |
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Objectives of Study: |
1. Primary objective: To identify molecular metabolic markers associated with PDAC metastasis through metabolomics sequencing data analysis combined with energy-dispersive CT imaging; to demonstrate the correlation between energy-dispersive CT characteristics of pancreatic cancer and tumor classification. 2. Secondary objective: To elucidate the expression levels of tumor metastasis-associated metabolites through spatial metabolomics sequencing; to identify cellular markers and molecular biomarkers for clinical molecular diagnostics of PDAC. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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纳入标准: |
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Inclusion criteria |
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排除标准: |
1.有其他恶性肿瘤病史;2.既往接受放疗、化疗等抗 PDAC 治疗;3.CT图像质量差;4.临床或病理资料不完整。 |
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Exclusion criteria: |
1.History of other malignant tumors; 2.Previous receipt of anti-PDAC treatments such as radiotherapy or chemotherapy; 3.Poor quality of CT images; 4.Incomplete clinical or pathological data. |
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研究实施时间: Study execute time: |
从 From 2026-03-30 00:00:00至 To 2028-12-31 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2026-03-30 00:00:00 至 To 2028-12-31 00:00:00 |
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干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
尚未开始 Not yet recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
无 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
none |
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是否公开试验完成后的统计结果: Calculated Results after the Study Completed public access: |
公开/Public |
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盲法: |
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Blinding: |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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是否共享原始数据: IPD sharing |
否No |
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共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址): |
无 |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
none |
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数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC: |
电子采集和管理 |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
Electronic Data Capture |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
暂未确定/Not yet |