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年龄对合并微血管侵犯的肝细胞癌术后病人预后的影响
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注册号:

Registration number:

ChiCTR2000029320 

最近更新日期:

Date of Last Refreshed on:

2020-01-25 

注册时间:

Date of Registration:

2020-01-24 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

年龄对合并微血管侵犯的肝细胞癌术后病人预后的影响 

Public title:

Poor Prognoses of Young Hepatocellular Carcinoma Patients with Microvascular Invasion: A Propensity Score-Matching Cohort Study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

伴有微血管侵犯的肝细胞癌患者预后 

Scientific title:

Prognoses of Hepatocellular Carcinoma Patients with Microvascular Invasion 

研究课题代号(代码):

Study subject ID:

国家自然科学基金会 (No. 71673193) 

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:

李练 

研究负责人:

张鸣 

Applicant:

Li Lian 

Study leader:

Zhang Ming 

申请注册联系人电话:

Applicant telephone:

+86 13281151891 

研究负责人电话:

Study leader's telephone:

+86 18980606723 

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:

liliandyx@163.com 

研究负责人电子邮件:

Study leader's E-mail:

48284728@qq.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:

四川省成都市国学巷37号 

研究负责人通讯地址:

四川省成都市国学巷37号 

Applicant address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China 

Study leader's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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:

四川大学华西医院 

Applicant's institution:

West China Hospital, Sichuan 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:

2020年审(8)号 

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:

四川大学华西医院生物医学伦理委员会 

Name of the ethic committee:

Biomedical ethics committee, west China hospital, sichuan university 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-01-14 

伦理委员会联系人:

李娜 

Contact Name of the ethic committee:

Li Na 

伦理委员会联系地址:

四川省成都市国学巷37号第八教学楼伦理委员会办公室 

Contact Address of the ethic committee:

Room 412, Old 8th Teaching Building, West China Hospital, Sichuan University, 37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China  

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 028 85422654 

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:

四川大学华西医院 

Primary sponsor:

West China Hospital, Sichuan University 

研究实施负责(组长)单位地址:

四川省成都市国学巷37号 

Primary sponsor's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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):

四川

市(区县):

Country:

China

Province:

Sichuan

City:

单位(医院):

四川大学华西医院

具体地址:

成都市国学巷37号

Institution
hospital:

West China Hospital, Sichuan University

Address:

37 Guoxue Lane, Chengdu, Sichuan, China

经费或物资来源:

中国国家自然科学基金会 (No. 71673193) 

Source(s) of funding:

National Natural Science Foundation of China (No. 71673193) 

研究疾病:

肝细胞癌 

Target disease:

Hepatocellular carcinoma 

研究疾病代码:

 

Target disease code:

 

研究类型:

预后研究 

Study type:

Prognosis study 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

探讨老年HCC患者与青年HCC患者在预后方面的差异。 

Objectives of Study:

To investigate the differences in prognosis between younger and older patients with HCC and MVI (HCC-MVI). 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

Patients with histologically confirmed HCC with MVI who underwent hepatectomy were retrospectively enrolled in this study and allocated to younger (young group) and older age groups (old group) according to age < or ≥60 years. A propensity score-matching analysis was performed and prognostic factors evaluated by Kaplan–Meier curves and Cox proportional hazards regression. 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

(1)身体状况良好,无重要器官功能障碍; (2)无其他恶性肿瘤病史; (3)病理证实的MVI; (4)进行了根治性切除。 

Inclusion criteria

(1) generally good condition without major organ dysfunction; (2) no history of another malignant tumour; (3) pathologically confirmed MVI; and (4) having undergone curative resection. 

排除标准:

(1)术后30天内复发或死亡; (2)肝切除术后行肝移植; (3)非根治性切除 

Exclusion criteria:

(1) recured or died within 30 days after surgery; (2) undergoing liver transplantation after hepatectomy; (3) non-radical resection  

研究实施时间:

Study execute time:

From2020-01-30To 2020-03-01 

征募观察对象时间:

Recruiting time:

From2020-02-20To 2020-03-01 

干预措施:

Interventions:

组别:

老年HCC患者组

样本量:

282

Group:

Senior HCC patients

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

组别:

青年HCC患者组

样本量:

92

Group:

Youth HCC patients

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

四川大学华西医院 

单位级别:

三甲医院 

Institution
hospital:

West China Hospital, Sichuan University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

disease-free survival and overall survival

指标类型:

主要指标 

Outcome:

disease-free survival and 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:

operative complications

指标类型:

次要指标 

Outcome:

operative complications

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:

tumor tissue

组织:

Sample Name:

tumor tissue

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):

回顾性队列研究

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

retrospective cohort study

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):

院内公开

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

Open in the hospital

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:

手动和电子采集及数字存储

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

Manual and electronic acquisition and digital storage

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-01-24
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