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慢性髓性白血病患者伊马替尼和尼洛替尼治疗中生活质量和毒副作用比较性研究
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注册号:

Registration number:

ChiCTR-OCH-11001699 

最近更新日期:

Date of Last Refreshed on:

2015-07-22 

注册时间:

Date of Registration:

2011-11-08 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

慢性髓性白血病患者伊马替尼和尼洛替尼治疗中生活质量和毒副作用比较性研究 

Public title:

The comparative study of quality of life and toxisities in patients with chronic myeloid leukemia during imatinib therapy vs. nilotinib therapy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

慢性髓性白血病患者伊马替尼和尼洛替尼治疗中生活质量和毒副作用比较性研究 

Scientific title:

The comparative study of quality of life and toxisities in patients with chronic myeloid leukemia during imatinib therapy vs. nilotinib therapy 

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:

江倩 

研究负责人:

黄晓军 

Applicant:

Qian Jiang 

Study leader:

Xiaojun Huang 

申请注册联系人电话:

Applicant telephone:

+86 10 66583802 

研究负责人电话:

Study leader's telephone:

+86 10 88326005 

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:

jiangqian@medmail.com.cn 

研究负责人电子邮件:

Study leader's E-mail:

xjhrm@medmail.com.cn 

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:

北京西直门南大街11号 

研究负责人通讯地址:

北京西直门南大街11号 

Applicant address:

11 Xizhimen South Street, Beijing 

Study leader's address:

11 Xizhimen South Street, Beijing 

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:

北京大学人民医院 北京大学血液病研究所 

Applicant's institution:

Peking University People's Hospital, Peking University Institute of Hematology 

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:

(2011) 伦审 第(18) 

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:

上海交通大学附属瑞金医院 

Name of the ethic committee:

Ruijin Hospital, Shanghai Jiaotong university school of medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2011-02-22 

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:

北京大学人民医院 北京大学血液病研究所 

Primary sponsor:

Peking University People's Hospital, Peking University Institute of Hematology 

研究实施负责(组长)单位地址:

北京西直门南大街11号 

Primary sponsor's address:

11 Xizhimen South Street, Beijing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京大学人民医院

具体地址:

北京西直门南大街11号

Institution
hospital:

Peking University People's Hospital

Address:

11 Xizhimen South Street, Beijing

经费或物资来源:

北京大学人民医院 北京大学血液病研究所 

Source(s) of funding:

Peking University People's Hospital, Peking University Institute of Hematology 

研究疾病:

慢性髓性白血病 

Target disease:

Chronic myeloid leukemia 

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:

III期临床试验 

Study phase:

研究目的:

比较慢性髓性白血病患者伊马替尼和尼洛替尼治疗中生活质量和毒副作用 

Objectives of Study:

To compare the quality of life and toxisities in patients with chronic myeloid leukemia during imatinib therapy vs nilotinib 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:

队列研究 

Study design:

Cohort study 

纳入标准:

接受伊马替尼和尼洛替尼治疗的慢性髓性白血病患者 

Inclusion criteria

Patients with chronic myeloid leukemia who received imatinib therapy vs nilotinib therapy 

排除标准:

严重脏器功能不全患者 

Exclusion criteria:

Patients with severe organ dysfunction 

研究实施时间:

Study execute time:

From2011-05-01To 2021-05-01 

征募观察对象时间:

Recruiting time:

From2011-05-01To 2016-05-01 

干预措施:

Interventions:

组别:

1

样本量:

100

Group:

one

Sample size:

干预措施:

伊马替尼

干预措施代码:

Intervention:

imatinib

Intervention code:

组别:

2

样本量:

80

Group:

two

Sample size:

干预措施:

尼洛替尼

干预措施代码:

Intervention:

imatinib

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京大学人民医院 

单位级别:

三甲医院 

Institution
hospital:

Peking University People's Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

SF-36表

指标类型:

主要指标 

Outcome:

SF-36 health survey

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肾功能

指标类型:

副作用指标 

Outcome:

Renal function

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

性功能

指标类型:

副作用指标 

Outcome:

Sexual function

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

甲状腺功能

指标类型:

副作用指标 

Outcome:

Thyriod function

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

凝血功能

指标类型:

副作用指标 

Outcome:

Coagulation function

Type:

Adverse events 

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:

征募研究对象情况:

Recruiting status:

结束

Completed

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):

按顺序

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

In order of administration

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

否No

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):

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

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:

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

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2011-11-08
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