注册号: Registration number: |
ChiCTR-DDT-12002848 |
最近更新日期: Date of Last Refreshed on: |
2015-12-27 |
注册时间: Date of Registration: |
2012-10-08 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
外周血循环DNA作为生物标志物在胃肠道肿瘤临床中的应用研究 |
Public title: |
Circulation cell-free DNA as a biomarker applied in clinical practice of gastrointestinal tumor |
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: |
外周血循环DNA作为生物标志物在胃肠道肿瘤临床中的应用研究 |
Scientific title: |
Circulation cell-free DNA as a biomarker applied in clinical practice of gastrointestinal tumor |
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: |
申请注册联系人: |
蒲汪旸 |
研究负责人: |
邢春根 |
Applicant: |
Pu wangyang |
Study leader: |
Xing chungen |
申请注册联系人电话: Applicant telephone: |
+86 13606137643 |
研究负责人电话: Study leader's telephone: |
+86 512 67784106 |
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: |
wangyang98375@163.com |
研究负责人电子邮件: Study leader's E-mail: |
xingcg@126.com |
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: |
苏州大学附属第二医院肿瘤科 |
研究负责人通讯地址: |
苏州大学附属第二医院普外科 |
Applicant address: |
Oncology department of The Second Affiliated Hospital of Soochow University |
Study leader's address: |
General surgery department of The Second Affiliated Hospital of Soochow University |
申请注册联系人邮政编码: Applicant postcode: |
215004 |
研究负责人邮政编码: Study leader's postcode: |
215004 |
申请人所在单位: |
苏州大学附属第二医院 |
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Applicant's institution: |
苏州大学附属第二医院 |
是否获伦理委员会批准: |
否 |
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Approved by ethic committee: |
NO |
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伦理委员会批件文号: Approved No. of ethic committee: |
伦理委员会批件附件: Approved file of Ethical Committee: |
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批准本研究的伦理委员会名称: |
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Name of the ethic committee: |
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伦理委员会批准日期: Date of approved by ethic committee: |
2013-08-26 | ||
伦理委员会联系人: |
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Contact Name of the ethic committee: |
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伦理委员会联系地址: |
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Contact Address of the ethic committee: |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
研究实施负责(组长)单位: |
苏州大学 |
Primary sponsor: |
Soochow University |
研究实施负责(组长)单位地址: |
苏州大学附属第二医院 |
Primary sponsor's address: |
The Second Affiliated Hospital of Soochow University |
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: |
自筹 |
Source(s) of funding: |
self-finance |
研究疾病: |
胃癌、结直肠癌 |
Target disease: |
gastric cancer, colorectal carcinoma |
研究疾病代码: |
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Target disease code: |
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研究类型: |
诊断试验 |
Study type: |
Diagnostic test |
研究所处阶段: |
其它 |
Study phase: |
N/A |
研究目的: |
评价血浆游离DNA浓度及完整性作为生物标志物在胃肠道肿瘤诊断及预后方面的作用 |
Objectives of Study: |
In the present project we propose to extraction of the cell-free DNA circulating in gastrointestinal tumor plasma in order to investigate whether both concentration and integrity of cell-free DNA may provide a reliable, predictive parameters for gastric cancer |
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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研究设计: |
诊断性病例对照试验 |
Study design: |
Diagnostic test: case-control |
纳入标准: |
新诊断的胃癌和结直肠癌患者 |
Inclusion criteria |
New cases of gastric cancer and colorectal carcinoma with pathological diagosis |
排除标准: |
新诊断的胃癌和结直肠癌患者 |
Exclusion criteria: |
1. cases combined with other malignant diseases; 2. cases combined autoimmune disease. |
研究实施时间: Study execute time: |
从From2013-01-01至To 2016-12-30 |
征募观察对象时间: Recruiting time: |
从From2013-01-01至To 2014-12-31 |
诊断试验: Diagnostic Tests: |
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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: |
结束 Completed |
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): |
方便选择 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
Convenience Selection |
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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原始数据公开时间: The time of sharing IPD: |
即时公开/Real time access |
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): |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
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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: |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
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数据管理委员会: Data Managemen Committee: |
暂未确定/Not yet |