今天是:2019-11-21 星期四

未知原发灶骨转移癌多学科优化诊治策略的临床研究
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注册号:

Registration number:

ChiCTR1900026785 

最近更新日期:

Date of Last Refreshed on:

2019-10-22 

注册时间:

Date of Registration:

2019-10-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

未知原发灶骨转移癌多学科优化诊治策略的临床研究 

Public title:

Study for optimized multidisciplinary diagonosis and treatment strategy for bone metastases of unknown origin 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

未知原发灶骨转移癌多学科优化诊治策略的临床研究 

Scientific title:

Study for optimized multidisciplinary diagonosis and treatment strategy for bone metastases of unknown origin 

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 

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:

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:

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:

骨肿瘤 

Target disease:

bone tumor 

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:

针对未知原发灶骨转移癌患者进行多学科协作的诊疗模式,提供包括放疗、化疗、手术治疗、康复治疗等在内的更加优化的及规范个性化的诊疗方案,建立并完善未知原发灶骨转移癌精准诊治体系治疗方案。 

Objectives of Study:

To develop and analysis the optimized multidisciplinary diagonosis and treatment strategy on bone metastases from unknown origin.And to give individual theraputic suuggestions for these patients, including radiotherapy, chemotherapy, surgery and rehabilitation treatment. 

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18-75岁。 3、骨转移癌原发灶不明确。  

Inclusion criteria

1. Signed informed consent; 2. Aged between 18 and 75 years; 3. Patient with bone metastases from unknown origin.  

排除标准:

1、研究对象未签署知情同意书; 2、中枢神经系统或者骨的原发肿瘤; 3、骨转移癌的原发肿瘤部位明确; 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; 6、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 bone; 3. The patients refused to be followed up; 4. Mental, intellectual disabilities or other communication disorders.  

研究实施时间:

Study execute time:

From2019-10-22To 2022-12-31 

干预措施:

Interventions:

组别:

多学科优化诊治组

样本量:

100

Group:

Case series

Sample size:

干预措施:

多学科优化诊治

干预措施代码:

Intervention:

Optimized multidisciplinary diagonosis and treatmen

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:

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):

上海交通大学附属第六人民医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai 6th People's Hospital Affiliated to Shanghai Jiao Tong University.  

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:

Fudan University Shanghai Cancer Center  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

总体生存时间

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:

治疗后生存时间

指标类型:

主要指标 

Outcome:

survival since treatment

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疾病无进展时间

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:

神经功能

指标类型:

主要指标 

Outcome:

neurologic function

Type:

Primary indicator 

测量时间点:

测量方法:

Frankel评分

Measure time point of outcome:

Measure method:

指标中文名:

疼痛状况

指标类型:

主要指标 

Outcome:

Pain

Type:

Primary indicator 

测量时间点:

测量方法:

VAS评分

Measure time point of outcome:

Measure method:

指标中文名:

并发症

指标类型:

主要指标 

Outcome:

complication

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:

组织:

Sample Name:

No

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:

尚未开始

Not yet 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):

N/A, Nonrandom.

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):

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 CRF and EDC.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-10-22
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