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脊柱转移性肿瘤流行病学的国际多中心研究
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注册号:

Registration number:

ChiCTR1800016920 

最近更新日期:

Date of Last Refreshed on:

2018-07-03 

注册时间:

Date of Registration:

2018-07-03 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

脊柱转移性肿瘤流行病学的国际多中心研究 

Public title:

Epidemiological study of spinal metastases: an international multicenter study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

脊柱转移性肿瘤流行病学的国际多中心研究 

Scientific title:

Epidemiological study of spinal metastases: an international multicenter study 

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:

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:

Department of Orthopaedic Oncology, Changzheng Hospital, 415 Fengyang Road, Shanghai, China 

Study leader's address:

Department of Orthopaedic Oncology, Changzheng Hospital, 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:

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:

上海市黄浦区凤阳路415号上海长征医院骨肿瘤科 

Primary sponsor's address:

Department of Orthopedic Oncology, Changzheng Hospital, Second Military Medical University, 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:

脊柱转移癌 

Target disease:

spinal metastases 

研究疾病代码:

 

Target disease code:

 

研究类型:

流行病学研究 

Study type:

Epidemilogical research 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

1、分析脊柱转移癌流行特征及其危险因素,探讨脊柱转移癌的发病原因、规律以及预防控制的措施; 2、收集就诊于各中心脊柱转移癌患者的基线资料、治疗措施并追踪其预后情况,建立脊柱转移癌疾病临床研究数据库,通过描述性、分析性和实验性流行病学方法,揭示脊柱转移癌人群的分布情况、影响因素和治疗措施,研究遗传和环境因素与脊柱转移癌发生的相关机制。 

Objectives of Study:

1. This research is designed to analyze the epidemiological characteristics and relevant risk factors of spinal metastases, which provide a basis for investigating the cause of high incidence of spinal metastases, to probe the regularity and prevention measures to cope with this status; 2. The demographic information, medical history, clinical characteristics and prognosis of the patients were collected which were used to establish the clinical research database of patients with spinal metastases, to reveal the distribution, influence factors and treatment measures, to study the association of spinal metastases occurrence with genetic and environment factors.  

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、年龄在18-75岁;3、脊柱转移癌诊断明确。 

Inclusion criteria

1. Signed informed consent; 2. Aged between 18 and 75 years; 3. Diagnosis of metastatic tumor of the spine.  

排除标准:

1、研究对象未签署知情同意书;2、原发肿瘤的中枢神经系统或者脊柱;3、拒绝接受随访的病例;4、存在精神、智力缺陷或其他交流障碍;5、任何其他不符合入选标准的患者。  

Exclusion criteria:

1. The objects refused to sign the informed consent; 2. The primary cancer site is central nervous system or spine; 3. The patients refused to be followed up; 4. Mental, intellectual disabilities or other communication disorders; 5. Any other do not conform the inclusion criteria.  

研究实施时间:

Study execute time:

From2018-07-15To 2023-07-15 

征募观察对象时间:

Recruiting time:

From2018-07-15To 2022-07-15 

干预措施:

Interventions:

组别:

连续病例

样本量:

1000

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:

印度 

省(直辖市):

Tamil Nādu 

市(区县):

 

Country:

India 

Province:

Tamil Nādu 

City:

 

单位(医院):

Apollo医院 

单位级别:

Tertiary A hospital 

Institution
hospital:

Apollo Hospital  

Level of the institution:

Tertiary A hospital 

国家:

印度 

省(直辖市):

Delhi 

市(区县):

 

Country:

India 

Province:

Delhi 

City:

 

单位(医院):

Artemis医院 

单位级别:

Tertiary A hospital 

Institution
hospital:

Artemis Hospital  

Level of the institution:

Tertiary A hospital 

国家:

澳大利亚 

省(直辖市):

melbourne 

市(区县):

 

Country:

Australia 

Province:

melbourne 

City:

 

单位(医院):

St Vincent‘s Private 

单位级别:

Tertiary A hospital 

Institution
hospital:

St Vincent‘s Private  

Level of the institution:

Tertiary A hospital 

国家:

马来西亚 

省(直辖市):

Selangor 

市(区县):

 

Country:

Malaysia 

Province:

Selangor 

City:

 

单位(医院):

Sunway医学中心 

单位级别:

Tertiary A hospital 

Institution
hospital:

Sunway medical center  

Level of the institution:

Tertiary A hospital 

国家:

澳大利亚 

省(直辖市):

Western Australia 

市(区县):

 

Country:

Australia 

Province:

Western Australia 

City:

 

单位(医院):

Sir Charles Gairdner医院 

单位级别:

Tertiary A hospital 

Institution
hospital:

Sir Charles Gairdner Hospital  

Level of the institution:

Tertiary A hospital 

国家:

日本 

省(直辖市):

大阪 

市(区县):

 

Country:

Japan 

Province:

Osaka 

City:

 

单位(医院):

大阪医学院医院 

单位级别:

Tertiary A hospital 

Institution
hospital:

Osaka Medical College Hospital  

Level of the institution:

Tertiary A hospital 

国家:

印度 

省(直辖市):

Mahārāshtra 

市(区县):

 

Country:

India 

Province:

Mahārāshtra 

City:

 

单位(医院):

Sancheti医院 

单位级别:

Tertiary A hospital 

Institution
hospital:

Sancheti Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

年龄

指标类型:

主要指标 

Outcome:

age

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

性别

指标类型:

主要指标 

Outcome:

gender

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

发病部位

指标类型:

主要指标 

Outcome:

location

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

病理类型

指标类型:

主要指标 

Outcome:

pathological type

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

基因突变

指标类型:

主要指标 

Outcome:

gene mutation

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:

本研究不采集人体标本

组织:

Sample Name:

This trial don't acquisition human specimens

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

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 18 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):

Nonrandom.

盲法:

Blinding:

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):

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:

 2018-07-03
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