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脊柱转移性肿瘤的外科治疗:一项多中心前瞻性研究
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注册号:

Registration number:

ChiCTR1800016921 

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:

脊柱转移性肿瘤的外科治疗:一项多中心前瞻性研究 

Public title:

Surgical treatment of spinal metastatic tumors: a multi-center prospective study  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

脊柱转移性肿瘤的外科治疗:一项多中心前瞻性研究 

Scientific title:

Surgical treatment of spinal metastatic tumors: a multi-center prospective 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:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

研究不同外科治疗方式在脊柱转移性肿瘤治疗中的价值,并为该部分患者的治疗方案制定提供相应的理论基础。 

Objectives of Study:

To access the value of different surgical strateges in the treatment of spinal metastatic tumors.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

1.经病理诊断明确为脊柱转移性肿瘤患者; 2.年龄大于等于18岁; 3.预计生存期大于3个月; 4.伴有神经功能障碍或脊柱症状,或伴有脊柱不稳(SINS大于6分); 5.签署知情同意书。  

Inclusion criteria

1. patients diagnosed with spinal metastatic tumor; 2. Aged over 18 years; 3. life expectancy longer than 3 months; 4. patients with neurological deficits or spinal instability (SINS≥6); 5. inform consent form signed  

排除标准:

1.脊柱原发肿瘤; 2.患者全身状况差,不能耐受手术、放疗、化疗、靶向药物等治疗; 3.正在参与其他RCT研究。  

Exclusion criteria:

1. primary spianl tumor; 2. patients with poor general conditions, and those who are intolerance of operation, radiotherapy, chemotherapy and target therapy; 3. patients participating other RCTs.  

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:

姑息手术组

样本量:

80

Group:

Palliative surgery group

Sample size:

干预措施:

姑息手术

干预措施代码:

Intervention:

Palliative surgery

Intervention code:

组别:

TES组

样本量:

40

Group:

TES group

Sample size:

干预措施:

en bloc全椎节切除

干预措施代码:

Intervention:

enbloc resection

Intervention code:

组别:

椎体成形组

样本量:

80

Group:

Vertebroplasty group

Sample size:

干预措施:

椎体成形

干预措施代码:

Intervention:

Vertebroplasty

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:

无进展生存时间

指标类型:

主要指标 

Outcome:

progression-free survival

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生存时间

指标类型:

主要指标 

Outcome:

overall survival

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Frankel 评分

指标类型:

主要指标 

Outcome:

Frankel Score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

VAS评分

指标类型:

主要指标 

Outcome:

VAS score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量评分

指标类型:

主要指标 

Outcome:

quality of life

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 80 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:

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):

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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