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Genomics and proteomics study on osteosarcoma
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注册号:

Registration number:

ChiCTR1800016325 

最近更新日期:

Date of Last Refreshed on:

2018-05-25 

注册时间:

Date of Registration:

2018-05-25 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

骨肉瘤的基因及蛋白组学研究 

Public title:

Genomics and proteomics study on osteosarcoma  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

骨肉瘤的基因及蛋白组学研究 

Scientific title:

Genomics and proteomics study on osteosarcoma  

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:

杨明磊 

研究负责人:

肖建如 

Applicant:

Minglei Yang 

Study leader:

Jianru Xiao 

申请注册联系人电话:

Applicant telephone:

+86 18817365100 

研究负责人电话:

Study leader's telephone:

+86 13701785283 

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:

ymlsmmu@163.com 

研究负责人电子邮件:

Study leader's E-mail:

jianruxiao83@163.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):

 

申请注册联系人通讯地址:

上海市黄浦区凤阳路415号上海长征医院骨肿瘤科 

研究负责人通讯地址:

上海市黄浦区凤阳路415号上海长征医院骨肿瘤科 

Applicant address:

415 Fengyang Road, Shanghai, China 

Study leader's address:

415 Fengyang 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:

 

申请人所在单位:

上海长征医院 

Applicant's institution:

Department of Orthopaedic Oncology, Shanghai Changzheng Hospital 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

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:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

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:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

上海长征医院 

Primary sponsor:

Shanghai Changzheng Hospital  

研究实施负责(组长)单位地址:

上海市凤阳路415号长征医院骨肿瘤外科 

Primary sponsor's address:

Department of Orthopaedic Oncology, Changzheng Hospital, 415 Fengyang Road, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海长征医院

具体地址:

上海市凤阳路415号长征医院骨肿瘤外科

Institution
hospital:

Shanghai Changzheng Hospital

Address:

415 Fengyang Road, Shanghai, China

经费或物资来源:

科研经费 

Source(s) of funding:

Grants for Scientific Research  

研究疾病:

骨肉瘤 

Target disease:

osteosarcoma 

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:

其它 

Study phase:

N/A 

研究目的:

分析骨肉瘤基因及蛋白组学表达谱,为进一步揭示骨肉瘤的发病机制奠定基础  

Objectives of Study:

To investigate the Genomics and proteomics profile of osteosarcoma, to further know more about the mechanism of osteosarcoma.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

1、签署了知情同意书;2、年龄低于75岁。3、骨肉瘤病理诊断明确。  

Inclusion criteria

1. Signed informed consent; 2. Aged under 75 years; 3. Patient diagnosed with osteosarcoma.  

排除标准:

1、研究对象未签署知情同意书;2、其他中枢神经系统或者脊柱的原发肿瘤;3、脊柱转移癌;4、拒绝接受随访的病例;5、存在精神、智力缺陷或其他交流障碍; 

Exclusion criteria:

1. The objects refused to sign the informed consent; 2. Other types of primary cancer of central nervous system or spine; 3. metastatic spinal tumor; 4. The patients refused to be followed up; 5. Mental, intellectual disabilities or other communication disorders.  

研究实施时间:

Study execute time:

From2017-12-01To 2020-12-01 

干预措施:

Interventions:

组别:

Case series

样本量:

200

Group:

Case series

Sample size:

干预措施:

NA

干预措施代码:

Intervention:

NA

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海长征医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Changzheng Hospital  

Level of the institution:

Tertiary A hospital  

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

华东师范大学,上海市调控生物学重点实验室,生命科学学院  

单位级别:

高等院校科研机构及重点实验室 

Institution
hospital:

Shanghai Key Laboratory of Regulatory Biology, School of Life Sciences, East China Normal University  

Level of the institution:

Research institution and key laboratory of University  

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

复旦大学计算机科学技术学院 

单位级别:

高等院校科研机构及重点实验室 

Institution
hospital:

School of Computer Science and Engineering,Fudan University  

Level of the institution:

Research institution and key laboratory of University  

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海交通大学系统生物医学研究院 

单位级别:

高等院校科研机构及重点实验室 

Institution
hospital:

Shanghai Center for Systems Biomedicine, Shanghai Jiao Tong University  

Level of the institution:

Research institution and key laboratory of University 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

同济大学医学院 

单位级别:

高等院校科研机构及重点实验室 

Institution
hospital:

School of Medicine, Tongji University  

Level of the institution:

Research institution and key laboratory of University 

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

陆军军医大学新桥医院 

单位级别:

三级甲等 

Institution
hospital:

Xinqiao Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

江苏 

市(区县):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

南京军区南京总院 

单位级别:

三级甲等 

Institution
hospital:

Nanjing General Hospital of Nanjing Military Region  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

成都军区成都总院 

单位级别:

三级甲等 

Institution
hospital:

Chengdu General Hospital of Chengdu Military Region  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

复旦大学附属肿瘤医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Cancer Center Fudan University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

云南 

市(区县):

 

Country:

China 

Province:

Yunnan 

City:

 

单位(医院):

云南省肿瘤医院 

单位级别:

三级甲等 

Institution
hospital:

Yunnan Cancer Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

基因组学

指标类型:

主要指标 

Outcome:

Genomics

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

蛋白组学

指标类型:

主要指标 

Outcome:

Proteomics

Type:

Primary 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:

血样

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

肿瘤组织

组织:

Sample Name:

Tumor sample

Tissue:

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 0 years
最大 Max age 75 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):

非随机。

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

N/A

盲法:

Blinding:

原始数据公开时间:

The time of sharing IPD:

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):

原始数据上传至发表学术刊物指定数据库

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

Upload the original data to database of the scientific publication

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:

数据收集采用CRF和EDC两种方式,保存于海军军医大学附属长征医院。

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

Data will be saved in Changzheng Hospital Affiliated to Naval Medical University by using CRFand EDC.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-05-25
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