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新型肿瘤标志物和治疗靶点基因的发现
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注册号:

Registration number:

ChiCTR2000039591 

最近更新日期:

Date of Last Refreshed on:

2020-11-02 

注册时间:

Date of Registration:

2020-11-02 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

新型肿瘤标志物和治疗靶点基因的发现 

Public title:

Discovery of new tumor markers and therapeutic target genes 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

9种癌症类型的50名患者肿瘤及邻近组织的转录组研究 

Scientific title:

Transcriptomes of paired tumour-adjacent tissues from 50 patients of 9 cancer types 

研究课题代号(代码):

Study subject ID:

 

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:

程超 

研究负责人:

孙陆果 

Applicant:

Chao Cheng 

Study leader:

Luguo Sun 

申请注册联系人电话:

Applicant telephone:

+86 13554373809 

研究负责人电话:

Study leader's telephone:

+86 13756986219 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

chaocheng@ablife.cc 

研究负责人电子邮件:

Study leader's E-mail:

sunlg388@nenu.edu.cn 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

https://www.ablife.cc/ 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

武汉市江夏区高新二路388号生物医药企业加速器二期18号楼1-2层 

研究负责人通讯地址:

吉林省长春市净月大街2555号 

Applicant address:

ABLife Inc., Optics Valley International Biomedical Park, Building 18 Floor 1-2, East Lake High-Tech Development Zone, 388 Second Gaoxin Road, Wuhan, Hubei, China  

Study leader's address:

2555 Jingyue Street, Changchun, Jilin, China 

申请注册联系人邮政编码:

Applicant postcode:

430075 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

武汉生命之美科技有限公司 

Applicant's institution:

Appreciate the Beauty of Life, Inc. 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2020081903 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

吉林大学中日联谊医院伦理委员会 

Name of the ethic committee:

Ethics Committee of China-Japan Union Hospital of Jilin University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-08-19 

伦理委员会联系人:

俞亭伊 

Contact Name of the ethic committee:

Tingyi Yu 

伦理委员会联系地址:

吉林省长春市仙台大街126号 

Contact Address of the ethic committee:

126 Xiantai Street, Changchun, Jilin, China 

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:

东北师范大学,药物基因和蛋白筛选国家工程实验室 

Primary sponsor:

National Engineering Laboratory for Druggable Gene and Protein Screening, Northeast Normal University 

研究实施负责(组长)单位地址:

吉林省长春市净月大街2555号 

Primary sponsor's address:

2555 Jinyue Street, Changchun, Jilin, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

吉林

市(区县):

长春

Country:

China

Province:

Jilin

City:

Changchun

单位(医院):

东北师范大学

具体地址:

净月大街2555号

Institution
hospital:

Northeast Normal University

Address:

126 Jingyue Street

经费或物资来源:

Fund for Directors of Pharmaceutical Genes and National Engineering Laboratory 

Source(s) of funding:

药物基因和蛋白筛选国家工程实验室主任基金 

研究疾病:

多种癌症 

Target disease:

Multiple cancers 

研究疾病代码:

 

Target disease code:

 

研究类型:

基础科学研究 

Study type:

Basic Science 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

开发出有潜在临床应用价值的恶性肿瘤临床防诊治生物标志物和药物作用靶点 

Objectives of Study:

To develop biomarkers for clinical prevention and treatment of malignant tumors and drug targets with potential clinical application value 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机抽样 

Study design:

Randomly Sampling 

纳入标准:

适合于手术治疗的癌症患者 

Inclusion criteria

Cancer patients suitable for surgical treatment 

排除标准:

未签署知情同意书 

Exclusion criteria:

Not signed informed consent 

研究实施时间:

Study execute time:

From2020-08-19To 2021-11-10 

征募观察对象时间:

Recruiting time:

From2020-08-19To 2021-11-10 

干预措施:

Interventions:

组别:

癌组织

样本量:

50

Group:

Tumor

Sample size:

干预措施:

手术

干预措施代码:

Intervention:

surgery

Intervention code:

组别:

癌旁组织

样本量:

50

Group:

Normal

Sample size:

干预措施:

手术

干预措施代码:

Intervention:

surgery

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

吉林省 

市(区县):

长春 

Country:

China 

Province:

Jilin 

City:

Changchun 

单位(医院):

吉林大学中日联谊医院 

单位级别:

三级甲等 

Institution
hospital:

China-Japan Union Hospital, Jilin University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

总生存期

指标类型:

主要指标 

Outcome:

OS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

分子标志物

指标类型:

附加指标 

Outcome:

Molecular Markers

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液和组织

组织:

癌及癌旁组织

Sample Name:

Blood and tissue

Tissue:

Cancer and adjacent tissues

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 13 years
最大 Max age 77 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

No

Randomization Procedure (please state who generates the random number sequence and by what method):

No

盲法:

N/A

Blinding:

N/A

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

ResMan (www.medresman.org); https://www.ncbi.nlm.nih.gov/geo (GSE87410)

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

ResMan (www.medresman.org); The data reported in this paper have been deposited with the NCBI Gene Expression Omnibus (GEO, https://www.ncbi.nlm.nih.gov/geo/) under accession number GSE87410

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:

EDC

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

EDC

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-11-02
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