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注册号: Registration number: |
ChiCTR2600120115 |
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最近更新日期: Date of Last Refreshed on: |
2026-03-09 18:01:28 |
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注册时间: Date of Registration: |
2026-03-09 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: |
NETs/METs诱发的神经焦亡介导胰腺癌快速进展的机制研究 |
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Public title: |
Mechanism of NETs/METs-Induced Neuroapoptosis Mediating the Rapid Progression of Pancreatic Cancer |
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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: |
NETs/METs诱发的神经焦亡介导胰腺癌快速进展的机制研究 |
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Scientific title: |
Mechanism of NETs/METs-Induced Neuroapoptosis Mediating the Rapid Progression of Pancreatic Cancer |
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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: |
朱琳佳 |
研究负责人: |
朱琳佳 |
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Applicant: |
Linjia Zhu |
Study leader: |
Linjia Zhu |
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申请注册联系人电话: Applicant telephone: |
+86 138 1397 2121 |
研究负责人电话:
Study leader's |
+86 138 1397 2121 |
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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: |
zhulinjia2010@163.com |
研究负责人电子邮件: Study leader's E-mail: |
zhulinjia2010@163.com |
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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: |
江苏省南京市鼓楼区广州路300号 |
研究负责人通讯地址: |
江苏省南京市鼓楼区广州路300号 |
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Applicant address: |
No. 300, Guangzhou Road, Gulou District, Nanjing City, Jiangsu Province |
Study leader's address: |
No. 300, Guangzhou Road, Gulou District, Nanjing City, Jiangsu Province |
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申请注册联系人邮政编码: Applicant postcode: |
研究负责人邮政编码: Study leader's postcode: |
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申请人所在单位: |
江苏省人民医院(南京医科大学第一附属医院) |
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Applicant's institution: |
Jiangsu Province Hospital ( The First Affiliated Hospital of Nanjing Medical University) |
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研究负责人所在单位: |
江苏省人民医院(南京医科大学第一附属医院) |
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Affiliation of the Leader: |
Jiangsu Province Hospital ( The First Affiliated Hospital of Nanjing Medical University) |
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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: |
2026-SR-009 |
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: |
南京医科大学第一附属医院伦理委员会 |
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Name of the ethic committee: |
The Ethics Committee of the First Affiliated Hospital of Nanjing Medical University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2026-01-21 00:00:00 | ||
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伦理委员会联系人: |
黄旭 |
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Contact Name of the ethic committee: |
Xu Huang |
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伦理委员会联系地址: |
江苏省南京市鼓楼区广州路300号 |
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Contact Address of the ethic committee: |
No. 300, Guangzhou Road, Gulou District, Nanjing City, Jiangsu Province |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 25 6830 6360 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
zhulinjia2010@163.com |
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研究实施负责(组长)单位: |
江苏省人民医院(南京医科大学第一附属医院) |
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Primary sponsor: |
Jiangsu Province Hospital ( The First Affiliated Hospital of Nanjing Medical University) |
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研究实施负责(组长)单位地址: |
江苏省南京市鼓楼区广州路300号 |
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Primary sponsor's address: |
No. 300, Guangzhou Road, Gulou District, Nanjing City, Jiangsu 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: |
国自然青年基金 |
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Source(s) of funding: |
National Natural Science Foundation of China - Young Scientists Fund |
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研究疾病: |
胰腺癌 |
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Target disease: |
pancreatic cancer |
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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: |
横断面 |
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Study design: |
Cross-sectional |
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研究目的: |
基于神经-肿瘤-免疫三位一体揭示神经焦亡介导胰腺癌快速进展的核心路径 |
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Objectives of Study: |
Based on the triad of neuro-tumor-immune revealing the core pathway of neuro-toxic apoptosis mediating the rapid progression of pancreatic cancer |
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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: |
排除标准: 1.非胰腺癌患者(如胃癌、肝癌、胆管癌等)或疑似胰腺其他类型的良性肿瘤(如胰腺囊肿); 2.肿瘤组织样本因坏死面积过大、取材不足等原因,无法满足实验检测要求的患者; 3.术前接受过放化疗、靶向治疗、免疫治疗等抗肿瘤治疗的患者; 4.存在严重的系统性疾病(如严重心肺疾病、肝肾功能衰竭、免疫缺陷等),这些疾病可能影响患者的治疗或生存状态; 5.存在严重感染,或处于免疫抑制状态的患者(如HIV感染者、免疫抑制药物使用者等); 6.既往有其他恶性肿瘤史,且当前肿瘤可能会影响胰腺癌的评估; 7.无法配合完成研究或提供知情同意书。 |
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Exclusion criteria: |
Exclusion criteria: 1. Patients with non-pancreatic cancer (such as gastric cancer, liver cancer, bile duct cancer, etc.) or suspected benign tumors of other types in the pancreas (such as pancreatic cysts); 2. Patients whose tumor tissue samples cannot meet the requirements for experimental detection due to excessive necrotic area or insufficient sampling; 3. Patients who have received anti-tumor treatments such as radiotherapy, chemotherapy, targeted therapy, or immunotherapy before the surgery; 4. Patients with severe systemic diseases (such as severe heart and lung diseases, liver and kidney failure, immune deficiency, etc.), which may affect the treatment or survival status of the patients; 5. Patients with severe infections or in an immunosuppressed state (such as HIV-infected individuals, users of immunosuppressive drugs, etc.); 6. Patients with a previous history of other malignant tumors, and the current tumor may affect the assessment of pancreatic cancer; 7. Patients who cannot cooperate with the study or provide informed consent. Tumor tissue and adjacent tissue samples for the study analysis. During the surgery, sufficient tumor tissue and adjacent tissue can be obtained for subsequent analysis; 5. Patients agree to participate in this study and sign the informed consent form. |
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研究实施时间: Study execute time: |
从 From 2026-03-09 00:00:00至 To 2029-01-01 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2026-03-09 00:00:00 至 To 2029-01-01 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: |
正在进行 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: |
无 |
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Blinding: |
None |
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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 |
是Yes |
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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): |
临床试验公共管理平台,http://www.medresman.org:22280/admin/index.aspx |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
ResMan,http://www.medresman.org:22280/admin/index.aspx |
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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: |
病例记录表 |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
Case Record Form |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
有/Yes |