Today is 2021-04-21

The guiding role of circulating tumor cell detection technology on TACE treatment and guiding prognosis in hepatocellular carcinoma after radical excision
download

注册号:

Registration number:

ChiCTR-OOC-16010183 

最近更新日期:

Date of Last Refreshed on:

2016-12-18 

注册时间:

Date of Registration:

2016-12-18 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

循环肿瘤细胞检测在人肝细胞癌根治性切除术后TACE治疗及其预后的指导作用 

Public title:

The guiding role of circulating tumor cell detection technology on TACE treatment and guiding prognosis in hepatocellular carcinoma after radical excision 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

循环肿瘤细胞检测技术指导伴有微血管侵犯的原发性肝癌R0切除术后TACE治疗的研究 

Scientific title:

The guiding role of circulating tumor cell detection technology on TACE treatment in hepatocellular carcinoma after radical excision with microvascular invasion 

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:

修鹏 

研究负责人:

李杰 

Applicant:

Xiu Peng 

Study leader:

Li Jie 

申请注册联系人电话:

Applicant telephone:

+86 18660103878 

研究负责人电话:

Study leader's telephone:

+86 13791120825 

申请注册联系人传真 :

Applicant Fax:

+86 0531-82963647 

研究负责人传真:

Study leader's fax:

+86 0531-82963647 

申请注册联系人电子邮件:

Applicant E-mail:

lcxiupeng@126.com 

研究负责人电子邮件:

Study leader's E-mail:

lijie0503@126.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:

山东省济南市经十路16766号肝胆外科 

研究负责人通讯地址:

山东省济南市经十路16766号肝胆外科 

Applicant address:

16766 Jingshi Road, Jinan, Shandong, China 

Study leader's address:

16766 Jingshi Road, Jinan, Shandong, 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:

山东省千佛山医院 

Applicant's institution:

Shandong Provincial Qianfoshan Hospital 

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:

2015S009 

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:

山东省千佛山医院伦理委员会 

Name of the ethic committee:

The ethic committee of Qianfoshan Hospital Shandong Province 

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:

山东省千佛山医院 

Primary sponsor:

Shandong Provincial Qianfoshan Hospital 

研究实施负责(组长)单位地址:

山东省济南市经十路16766号千佛山医院 

Primary sponsor's address:

16766 Jingshi Road, Jinan, Shandong, 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):

山东

市(区县):

济南

Country:

China

Province:

Shandong

City:

Jinan

单位(医院):

千佛山医院

具体地址:

济南经十路16766号

Institution
hospital:

Qianfoshan Hospital

Address:

16766 Jingshi Road, Jinan, Shandong, China

国家:

中国

省(直辖市):

湖北

市(区县):

武汉

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

华中科技大学同济医学院附属同济医院

具体地址:

湖北省武汉市解放大道1095号

Institution
hospital:

TongJi Hospital TongJi Medical College Huazhong University of Science and Technology

Address:

1095 Jiefang Avenue, Qiaokou District, Wuhan, Hubei, China

经费或物资来源:

科技部重点研发计划 

Source(s) of funding:

National Major Research and Development Program of China  

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:

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:

以外周血/区域回流静脉血CTCs检测及患者无瘤生存期为主要评价指标,明确伴有微血管侵犯的原发性肝癌根治性切除术后行TACE治疗的指证 

Objectives of Study:

To determin the surgical indications on TACE treatment in hepatocellular carcinoma after radical excision with microvascular invasion by using the circulating tumor cell detection technology with peripheral blood and disease free survival as the major evaluating indicator. 

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:

符合原发性肝癌诊疗规范的临床诊断标准,行根治性切除患者结合术后病理证实为肝细胞肝癌,同时心肺等重要脏器功能可以耐受相关治疗,患者各项临床病理资料齐全,未行其他特殊抗癌治疗,无其他癌症病史。 

Inclusion criteria

According to the clinical diagnostic standard of primary liver cancer diagnosis standard, patients with radical resection combined with postoperative pathology confirmed hepatocellular carcinoma at the same time, an important function of heart and lung and other organs can be tolerated treatment, the patients with complete clinical and pathological data, no other special anticancer therapy, no other history of cancer. 

排除标准:

病理证实为非肝细胞肝癌的患者;有严重心、肝、肺、脑、肾等脏器合并症;因各种原因失访。 

Exclusion criteria:

Pathology confirmed that patients with non hepatocellular carcinoma; severe heart, liver, lung, brain, kidney and other organ complications; due to various reasons lost. 

研究实施时间:

Study execute time:

From2016-07-01To 2018-12-31 

征募观察对象时间:

Recruiting time:

From2016-12-01To 2018-06-30 

干预措施:

Interventions:

组别:

TACE治疗组

样本量:

80

Group:

TACE treatment group

Sample size:

干预措施:

TACE

干预措施代码:

Intervention:

TACE

Intervention code:

组别:

对照组

样本量:

120

Group:

Control

Sample size:

干预措施:

不使用TACE

干预措施代码:

Intervention:

without TACE

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

山东 

市(区县):

济南 

Country:

China 

Province:

Shandong 

City:

Jinan 

单位(医院):

山东省千佛山医院 

单位级别:

三级甲等 

Institution
hospital:

Qianfoshan Hospital  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

华中科技大学同济医学院附属同济医院 

单位级别:

三级甲等 

Institution
hospital:

TongJi Hospital TongJi Medical College Huazhong University of Science and Technology  

Level of the institution:

Tertiary Hospital 

测量指标:

Outcomes:

指标中文名:

无瘤生存期

指标类型:

主要指标 

Outcome:

disease free survival

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:

正在进行

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):

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

None

盲法:

Blinding:

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):

2019.01.01

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

01st, January, 2019

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:

包括CRF表,CTC检测图片、知情同意书等

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

Including CRF table, CTC test images, informed consent, etc.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-12-18
return list