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Real-world study for pegfilgrastim(Jinyouli) in preventing neutropenia after chemotherapy in patients with ovarian cancer
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注册号:

Registration number:

ChiCTR1900027961 

最近更新日期:

Date of Last Refreshed on:

2019-12-07 

注册时间:

Date of Registration:

2019-12-07 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

聚乙二醇化重组人粒细胞集落刺激因子(津优力)预防卵巢癌患者化疗后中性粒细胞减少的真实世界研究 

Public title:

Real-world study for pegfilgrastim(Jinyouli) in preventing neutropenia after chemotherapy in patients with ovarian cancer 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

聚乙二醇化重组人粒细胞集落刺激因子(津优力)预防卵巢癌患者化疗后中性粒细胞减少的真实世界研究 

Scientific title:

Real-world study for pegfilgrastim(Jinyouli) in preventing neutropenia after chemotherapy in patients with ovarian cancer 

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:

康山 

研究负责人:

康山 

Applicant:

Shan Kang 

Study leader:

Shan Kang 

申请注册联系人电话:

Applicant telephone:

+86 13832325100 

研究负责人电话:

Study leader's telephone:

+86 13832325100 

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:

ksjq62@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

ksjq62@sina.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:

河北省石家庄市健康路12号 

研究负责人通讯地址:

河北省石家庄市健康路12号 

Applicant address:

12 Jiankang Road, Shijiazhuang, Hebei, China 

Study leader's address:

12 Jiankang Road, Shijiazhuang, Hebei, 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:

河北医科大学第四医院 

Applicant's institution:

The Fourth Hospital of Hebei Medical University 

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:

2019031 

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:

河北医科大学第四医院医学伦理委员会 

Name of the ethic committee:

Ethics Committee of the Fourth Hospital of Hebei Medical University  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-03-21 

伦理委员会联系人:

张俊敏 

Contact Name of the ethic committee:

Junmin Zhang 

伦理委员会联系地址:

河北省石家庄市健康路12号 

Contact Address of the ethic committee:

12 Jiankang Road, Shijiazhuang, Hebei, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 13831120853 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

0311-86095794 

研究实施负责(组长)单位:

河北医科大学第四医院 

Primary sponsor:

The Fourth Hospital of Hebei Medical University 

研究实施负责(组长)单位地址:

河北省石家庄市健康路12号 

Primary sponsor's address:

12 Jiankang Road, Shijiazhuang, Hebei, 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):

河北省

市(区县):

石家庄市

Country:

China

Province:

Hebei

City:

Shijiazhuang

单位(医院):

河北医科大学第四医院

具体地址:

河北省石家庄市健康路12号

Institution
hospital:

The Fourth Hospital of Hebei Medical University

Address:

12 Jiankang Road, Shijiazhuang, Hebei

经费或物资来源:

石药集团百克(山东)生物制药有限公司 

Source(s) of funding:

China Shijiazhuang Pharmaceutical Company (CSPC) Baike (Shandong) Biopharmaceutical Co. Ltd. 

研究疾病:

卵巢癌 

Target disease:

ovarian cancer 

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:

上市后药物 

Study phase:

研究目的:

观察和评价聚乙二醇化重组人粒细胞集落刺激因子(津优力)预防卵巢癌患者化疗后中性粒细胞减少在真实世界中的有效性、安全性。 

Objectives of Study:

To observe and evaluate the efficacy and safety of pegfilgrastim(jinyouli) in the prevention of neutropenia in patients with ovarian cancer after chemotherapy in the real world. 

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.年龄:≥18岁; 2.经病理学或组织学确诊的卵巢癌患者; 3.拟计划施行化疗且化疗结束后预防使用津优力; 4.患者精神意识良好,理解本临床试验相关并自愿加入本研究,签署知情同意书; 5.研究者认为可获益。 

Inclusion criteria

1. Aged >=18 years old; 2. Breast cancer patients diagnosed by pathology or histology; 3. Patients who plan to receive receive chemotherapy, and use jinyuli prophylactically after chemotherapy; 4. Patients with good mental awareness, understand the clinical Investigate and voluntarily join the study and sign an informed consent; 5. Researchers believe that patients can benefit. 

排除标准:

1.已证实对津优力或rhG-CSF和/或其辅料过敏者; 2.怀孕或哺乳期妇女以及在临床观察期间计划怀孕的妇女; 3.医生认为不适合纳入的其他患者。 

Exclusion criteria:

1. Those who have been confirmed to be allergic to pegfilgrastim or rhG-CSF and/or its excipients; 2. Pregnant or lactating women and women who plan to become pregnant during clinical observation; 3. Other patients considered unsuitable by doctors.  

研究实施时间:

Study execute time:

From2018-11-12To 2021-05-18 

征募观察对象时间:

Recruiting time:

From2019-12-05To 2020-12-05 

干预措施:

Interventions:

组别:

PEG-rhG-CSF组

样本量:

500

Group:

PEG-rhG-CSF group

Sample size:

干预措施:

化疗结束24小后,下一次化疗12天前,皮下注射津优力(PEG-rhG-CSF) 6mg

干预措施代码:

Intervention:

After 24 hours of chemotherapy, and 12 days before the next cycle of chemotherapy, subcutaneous injection of Jinyouli (PEG-rhG-CSF) 6mg

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

河北省 

市(区县):

石家庄市 

Country:

China 

Province:

Hebei 

City:

Shijiazhuang 

单位(医院):

河北医科大学第四医院 

单位级别:

三级甲等医院 

Institution
hospital:

The Fourth Hospital of Hebei Medical University  

Level of the institution:

Tertiary A Hospital  

测量指标:

Outcomes:

指标中文名:

FN的发生率

指标类型:

主要指标 

Outcome:

incidence rate of FN

Type:

Primary indicator 

测量时间点:

测量方法:

血常规

Measure time point of outcome:

Measure method:

Routine blood test

指标中文名:

Ⅳ度中性粒细胞减少发生率

指标类型:

次要指标 

Outcome:

Incidence of grade IV neutropenia

Type:

Secondary indicator 

测量时间点:

测量方法:

血常规

Measure time point of outcome:

Measure method:

Routine blood test

指标中文名:

化疗延迟(因任何原因化疗推迟进行≥3d)发生率和持续时间

指标类型:

次要指标 

Outcome:

Incidence and duration of chemotherapy delay (for any reason, chemotherapy delay time is greater than or equal to 3 days)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

化疗剂量降低的发生率

指标类型:

次要指标 

Outcome:

Incidence of chemotherapy dose reduction

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

相对剂量强度

指标类型:

次要指标 

Outcome:

Relative dose intensity

Type:

Secondary 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:

标本中文名:

尿液

组织:

Sample Name:

Urine

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 18 years
最大 Max age years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

不适用,单臂试验

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

NA, single arm study

盲法:

开放

Blinding:

Open

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

文章发表

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

Article 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:

电子采集和管理系统

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

Electronic Data Capture(EDC)

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-12-07
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