今天是:2019-12-07 星期六

白介素-32在骨髓瘤患者骨髓中的表达以及预后意义
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注册号:

Registration number:

ChiCTR1900022937 

最近更新日期:

Date of Last Refreshed on:

2019-05-04 

注册时间:

Date of Registration:

2019-05-04 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

白介素-32在骨髓瘤患者骨髓中的表达以及预后意义 

Public title:

Expression of interleukin-32 in bone marrow of patients with myeloma and its prognostic significance 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

白介素-32在骨髓瘤患者骨髓中的表达以及预后意义 

Scientific title:

Expression of interleukin-32 in bone marrow of patients with myeloma and its prognostic significance 

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:

王刚 

研究负责人:

王刚 

Applicant:

Gang Wang 

Study leader:

Gang Wang 

申请注册联系人电话:

Applicant telephone:

+86 13676610498 

研究负责人电话:

Study leader's telephone:

+86 13676610498 

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:

wg182110@sohu.com 

研究负责人电子邮件:

Study leader's E-mail:

wg182110@sohu.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:

浙江省衢州市柯城区钟楼底2号 

研究负责人通讯地址:

浙江省衢州市柯城区钟楼底2号 

Applicant address:

2 Zhong-Lou-Di Street, Kecheng District, Quzhou, Zhejiang, China 

Study leader's address:

2 Zhong-Lou-Di Street, Kecheng District, Quzhou, Zhejiang, 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:

衢州市人民医院 

Applicant's institution:

People's hospital of Quzhou 

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:

QZ-1092 

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:

衢州市人民医院临床试验伦理委员会 

Name of the ethic committee:

Clinical Trial Ethics Committee of People's Hospital of Quzhou  

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

张运强 

Contact Name of the ethic committee:

Yunqiang Zhang 

伦理委员会联系地址:

浙江省衢州市柯城区钟楼底2号 

Contact Address of the ethic committee:

2 Zhong-Lou-Di Street, Kecheng District, Quzhou, Zhejiang, 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:

衢州市人民医院 

Primary sponsor:

People's Hospital of Quzhou 

研究实施负责(组长)单位地址:

浙江省衢州市柯城区钟楼底2号 

Primary sponsor's address:

2 Zhong-Lou-Di Street, Kecheng District, Quzhou, Zhejiang, 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):

浙江省

市(区县):

Country:

China

Province:

Zhejiang

City:

单位(医院):

衢州市人民医院

具体地址:

浙江省衢州市柯城区钟楼底2号

Institution
hospital:

People's Hospital of Quzhou

Address:

2 Zhong-Lou-Di Street, Kecheng District, Quzhou, Zhejiang, China

经费或物资来源:

衢州市人民医院优秀青年医学人才基金 

Source(s) of funding:

Excellent Young Medical Talent Fund of People's Hospital Quzhou  

研究疾病:

多发性骨髓瘤 

Target disease:

Multiple Myeloma 

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:

本研究的目的是评估诱导治疗结束后白介素32与多发性骨髓瘤(Multiple Myeloma,MM)临床结果的关系。 

Objectives of Study:

The aim of this study is to evaluate the relationship between interleukin-32 (IL-32) and multiple myeloma (MM) clinical outcomes after induction therapy.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

符合国际骨髓瘤工作组(International Myeloma Working Group,IMWG)的诊断标准; 

Inclusion criteria

All patients met the diagnostic criteria of the International Myeloma Working Group (IMWG)  

排除标准:

排除标准包括:1)患者预计生存时间<3个月,不能接受长期随访,2)因其他疾病接受过放、化疗及相关药物治疗;3)合并其他恶性肿瘤或严重感染的患者。 

Exclusion criteria:

1) the survival time of patients is expected less than 3 months and long-time follow up isnt performed; 2) The patient was treated with radiotherapy, chemotherapy and related drugs for other diseases; 3) patients with other malignant tumors or serious infections.  

研究实施时间:

Study execute time:

From2019-06-01To 2024-06-01 

干预措施:

Interventions:

组别:

IL-32≥856.4 组

样本量:

40

Group:

IL-32≥856.4 Group

Sample size:

干预措施:

No

干预措施代码:

Intervention:

No

Intervention code:

组别:

IL-32<856.4 组

样本量:

30

Group:

IL-32<856.4 Group

Sample size:

干预措施:

No

干预措施代码:

Intervention:

No

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江省 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

衢州市人民医院 

单位级别:

三甲 

Institution
hospital:

People's Hospital of Quzhou  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

血β2-微球蛋白水平

指标类型:

主要指标 

Outcome:

β2-MG

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白蛋白

指标类型:

主要指标 

Outcome:

ALB

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

C反应蛋白

指标类型:

主要指标 

Outcome:

CRP

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白介素-32

指标类型:

主要指标 

Outcome:

IL-32

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:

血液

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:

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 years
最大 Max age 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):

不随机

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

N/A

盲法:

N/A

Blinding:

N/A

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):

Excel

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

Excel

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:

SPSS和EXCEL

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

SPSS and EXCEL

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-05-04
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