注册号: Registration number: |
ChiCTR1800019877 |
最近更新日期: Date of Last Refreshed on: |
2018-12-05 |
注册时间: Date of Registration: |
2018-12-05 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
中国非小细胞肺癌患者外周血外泌体miRNAs作为早诊生物标志物的前瞻性研究 |
Public title: |
An prospective study for the early diagnosis of non-small-cell lung cancer by peripheral blood exosomal miRNAs biomarker detection |
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: |
中国非小细胞肺癌患者外周血外泌体miRNAs作为早诊生物标志物的前瞻性研究 |
Scientific title: |
An prospective study for the early diagnosis of non-small-cell lung cancer by peripheral blood exosomal miRNAs biomarker detection |
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: |
郑迪 |
研究负责人: |
郑迪 |
Applicant: |
Di Zheng |
Study leader: |
Di Zheng |
申请注册联系人电话: Applicant telephone: |
+86 13801683953 |
研究负责人电话: Study leader's telephone: |
+86 13801683953 |
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: |
zhengdiok@hotmail.com |
研究负责人电子邮件: Study leader's E-mail: |
zhengdiok@hotmail.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: |
上海市杨浦区政民路507号 |
研究负责人通讯地址: |
上海市杨浦区政民路507号 |
Applicant address: |
507 Zhengmin Road, Shanghai, China |
Study leader's address: |
507 Zhengmin Road, Shanghai, China |
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: |
上海市肺科医院 |
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Applicant's institution: |
Shanghai Pulmonary Hospital |
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: |
K18-199Y |
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: |
上海市肺科医院医学伦理委员会 |
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Name of the ethic committee: |
Medical ethics committee of Shanghai pulmonary hospital |
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伦理委员会批准日期: Date of approved by ethic committee: |
2018-11-30 | ||
伦理委员会联系人: |
桂涛 |
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Contact Name of the ethic committee: |
Tao Gui |
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伦理委员会联系地址: |
上海市肺科医院 |
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Contact Address of the ethic committee: |
Shanghai Pulmonary Hospital Tongji University School of Medicine, 507 Zhengmin Road, Shanghai, China |
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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: |
上海市肺科医院 |
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Primary sponsor: |
Shanghai Pulmonary Hospital |
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研究实施负责(组长)单位地址: |
上海市杨浦区政民路507号 |
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Primary sponsor's address: |
507 Zhengmin Road, Shanghai, China |
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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: |
自筹 |
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Source(s) of funding: |
self-financing |
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研究疾病: |
非小细胞肺癌 |
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Target disease: |
Non small cell lung 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: |
病因学/相关因素研究 |
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Study type: |
Cause/Relative factors study |
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研究所处阶段: |
基础科学研究 | ||||||||||||||||||||||
Study phase: |
Basic Science |
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研究目的: |
鉴定能够区分腺癌(AC)和良性肿瘤的外体microRNA生物标志物作为早期诊断非小细胞肺癌的非侵袭性方法。 |
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Objectives of Study: |
To identify exosomal microRNAs that are able to discriminate between adenocarcinoma (AC) and benign tumors as a non-invasive method in the early diagnosis of non-small-cell lung 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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研究设计: |
队列研究 |
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Study design: |
Cohort study |
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纳入标准: |
①胸部CT检测提示肺部结节病灶。 ②拟进行肺部结节病灶手术切除。 |
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Inclusion criteria |
1. Chest CT examination suggests a pulmonary nodule lesion; 2. It is planned to perform surgical resection of pulmonary nodule lesions. |
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排除标准: |
①目前正在参加其他的临床研究。 ②任何精神病或认知障碍,从而限制受试者对知情同意书的理解和签署。 ③不能按照临床研究要求和方案的要求,参与临床研究。 ④曾经或现在已明确患有恶性肿瘤疾病。 |
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Exclusion criteria: |
1. Currently participating in other clinical studies; 2. Any mental illness or cognitive impairment that limits the subject's understanding and signature of the informed consent form; 3. Can not participate in clinical research according to the requirements of clinical research requirements and programs; 4. It has been or is now clearly diagnosed with a malignant tumor. |
研究实施时间: Study execute time: |
从From2019-01-01至To 2021-12-31 |
征募观察对象时间: Recruiting time: |
从From2019-01-01至To 2020-09-30 |
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): |
N/A |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
N/A |
盲法: |
N/A |
Blinding: |
N/A |
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 |
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): |
原始数据公开于中国临床试验注册中Resman(http://www.medresman.org) |
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
The original data will public on website within six months after the trial complete: Resman(http://www.medresman.org) |
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: |
采用SPSS数据库和Excel等保存原始数据 |
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
use SPSS database and Excel etc. to save the original data |
数据与安全监察委员会: Data and Safety Monitoring Committee: |
暂未确定/Not yet |