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中华医学会外科学分会乳腺外科学组多中心乳腺癌保乳治疗的临床调查研究
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注册号:

Registration number:

ChiCTR1900026841 

最近更新日期:

Date of Last Refreshed on:

2019-10-24 

注册时间:

Date of Registration:

2019-10-24 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

中华医学会外科学分会乳腺外科学组多中心乳腺癌保乳治疗的临床调查研究 

Public title:

Multi-center breast-conserving surgery situation research based on Breast Surgery Group of the Chinese Medical Association Surgery Society 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中华医学会外科学分会乳腺外科学组多中心乳腺癌保乳治疗的临床调查研究 

Scientific title:

Multi-center breast-conserving surgery situation research based on Breast Surgery Group of the Chinese Medical Association Surgery Society 

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:

刘丽媛 

研究负责人:

余之刚 

Applicant:

Liyuan Liu 

Study leader:

Zhigang Yu 

申请注册联系人电话:

Applicant telephone:

+86 0531 85875048 

研究负责人电话:

Study leader's telephone:

+86 13864182636 

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:

liuliyuan@sdu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

yuzhigang@sdu.edu.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:

中国山东省济南市天桥区北园大街247号 

研究负责人通讯地址:

中国山东省济南市天桥区北园大街247号 

Applicant address:

247 Beiyuan Road, Ji'nan, Shandong, China 

Study leader's address:

247 Beiyuan Road, Ji'nan, 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:

山东大学第二医院 

Applicant's institution:

The Second Hospital of Shandong 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:

KYLL-2019(KJ)P-0082 

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:

山东大学第二医院科研伦理委员会 

Name of the ethic committee:

The Institutional Review Board (IRB) of the Second Hospital of Shandong University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-07-17 

伦理委员会联系人:

鲜于俊杰 

Contact Name of the ethic committee:

Xianyu Junjie 

伦理委员会联系地址:

中国山东省济南市天桥区北园大街247号 

Contact Address of the ethic committee:

247 Beiyuan Road, Ji'nan, Shandong, 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:

山东大学第二医院 

Primary sponsor:

The Second Hospital of Shandong University 

研究实施负责(组长)单位地址:

中国山东省济南市天桥区北园大街247号 

Primary sponsor's address:

247 Beiyuan Road, Ji'nan, 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):

山东省

市(区县):

济南市

Country:

China

Province:

Shandong

City:

Jinan

单位(医院):

山东大学第二医院

具体地址:

中国山东省济南市天桥区北园大街247号

Institution
hospital:

The Second Hospital of Shandong University

Address:

247 Beiyuan Road, Ji'nan, Shandong, China

经费或物资来源:

课题经费 

Source(s) of funding:

research funding 

研究疾病:

乳腺癌 

Target disease:

Breast 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:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

研究我国乳腺癌保乳手术治疗现状,以期为乳腺癌保乳手术的临床决策的制定提供参考 

Objectives of Study:

To explore the present situation of breast-conserving therapy in China, so as to provide reference for the clinical decision of breast conserving surgery. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

1.来自中华医学会外科学分会乳腺外科学组成员单位的乳腺癌患者; 2.女性乳腺癌患者; 3.有病理明确诊断为乳腺癌并施行保乳手术者; 4.有完整的病例资料:,包括年龄、月经状态、影像学检查、肿瘤大小、病理类型、腋窝淋巴结转移情况、脉管癌栓、ER、PR、HER2、Ki-67 及术后治疗方式等 

Inclusion criteria

1. Breast cancer patients from member hospital of Breast Surgery Group of the Chinese Medical Association Surgery Society; 2. Female breast cancer; 3. Patients are clearly diagnosed as breast cancer pathologically and accept an breast-conserving surgery; 4. Patients with complete clinical data: including age, menstrual status, imaging examination, tumor size, pathological type, axillary lymph node metastasis, vascular tumor thrombus, ER, PR, HER2, Ki-67 and postoperative treatment ect. 

排除标准:

1.保乳手术前已有远处转移; 2.炎性乳腺癌; 3.男性乳腺癌患者; 4.病理诊断结果缺失或临床病理资料不全的患者; 5.非学组成员单位病人。 

Exclusion criteria:

1. Distant metastasis has been happen before surgery; 2. Inflammatory breast cancer; 3. Male breast cancer; 4. Patients with missing pathological findings or incomplete clinical pathology; 5. Patients from non-scholar member unit. 

研究实施时间:

Study execute time:

From2019-01-01To 2021-12-31 

征募观察对象时间:

Recruiting time:

From2019-01-01To 2021-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

3000

Group:

Case series

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):

山东省 

市(区县):

济南市 

Country:

China 

Province:

Shandong 

City:

Jinan 

单位(医院):

山东大学第二医院 

单位级别:

三级甲等 

Institution
hospital:

The second hospital of Shandong University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

保乳率

指标类型:

主要指标 

Outcome:

breast-conserving rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后外观满意度

指标类型:

次要指标 

Outcome:

Postoperative cosmetic satisfaction

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疾病复发率

指标类型:

主要指标 

Outcome:

relapse

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

远处转移

指标类型:

主要指标 

Outcome:

metastasis

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

使用后保存 

说明

Fate of sample:

Preservation 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:

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

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

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/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):

ResMan; 原始数据在试验完成后6个月通过研究负责人电子邮件联系获取

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

ResMan; The raw data can be accessed by e-mail of PI in 6 months after the research finished

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:

病例记录表CRF

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

Case Record Form

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-10-24
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