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预处理外周血中性粒细胞与淋巴细胞比值对新辅助化疗反应和乳腺癌预后的预测价值
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注册号:

Registration number:

ChiCTR2000034559 

最近更新日期:

Date of Last Refreshed on:

2020-07-13 

注册时间:

Date of Registration:

2020-07-10 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

预处理外周血中性粒细胞与淋巴细胞比值对新辅助化疗反应和乳腺癌预后的预测价值 

Public title:

Predictive Value of Pretreatment Peripheral Neutrophil-to-Lymphocyte Ratio for Response to Neoadjuvant Chemotherapy and Breast Cancer Prognosis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

Predictive Value of Pretreatment Peripheral Neutrophil-to-Lymphocyte Ratio for Response to Neoadjuvant Chemotherapy and Breast Cancer Prognosis 

Scientific title:

Predictive Value of Pretreatment Peripheral Neutrophil-to-Lymphocyte Ratio for Response to Neoadjuvant Chemotherapy and Breast Cancer Prognosis 

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:

李小敏 

研究负责人:

羊晓勤 

Applicant:

Li Xiaomin 

Study leader:

Yang Xiaoqin 

申请注册联系人电话:

Applicant telephone:

+86 13594854377 

研究负责人电话:

Study leader's telephone:

+86 18980605792 

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:

2018224025365@stu.scu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

xiaoqinyang2019@outlook.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:

中国四川省成都市武侯区人民南路三段17号 

研究负责人通讯地址:

中国四川省成都市武侯区国学巷37号 

Applicant address:

17 Renmin Road South, 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 School of Medicine, 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:

N/A 

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:

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:

2019-02-01 

伦理委员会联系人:

孙荣国 

Contact Name of the ethic committee:

Sun Rongguo 

伦理委员会联系地址:

中国四川省成都市武侯区国学巷37号四川大学华西医院老八教412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:

 

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:

中国四川省成都市武侯区国学巷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):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

华西医院

具体地址:

四川省成都市武侯区国学巷37号

Institution
hospital:

West China hospital

Address:

37 Guoxue Lane, Wuhou District

经费或物资来源:

研究生项目 

Source(s) of funding:

postgraduate subjects  

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:

探讨中性粒细胞与淋巴细胞比值(NLR)对新辅助化疗疗效的预测价值乳腺癌(NAC)及NAC后NLR与阳性淋巴结比率(LNR)的相关性。同时,还探讨了NLR和LNR的预后价值。 

Objectives of Study:

To evaluate the predictive value of neutrophil-to-lymphocyte ratio (NLR) for the response of neoadjuvant chemotherapy (NAC) in breast cancer, and the correlation between NLR and positive lymph node ratio (LNR) after NAC. At the same time, the prognostic value of both NLR and LNR was also studied. 

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) 在NAC前经核心针活检诊断为原发性乳腺癌; (2)女性和临床I-III期; (3)接受NAC及随后的乳房切除术或保乳手术。 

Inclusion criteria

(1) diagnosed as primary breast cancer by core needle biopsy before NAC; (2) female and clinical stage I-III; (3) received NAC and subsequent mastectomy or breast-conserving surgery. 

排除标准:

(1)炎症性乳腺癌; (2)IV期疾病; (3)妊娠相关乳腺癌。 

Exclusion criteria:

(1) inflammatory breast cancer; (2) stage IV disease; (3) pregnancy-associated breast cancer. 

研究实施时间:

Study execute time:

From2020-08-01To 2020-12-31 

征募观察对象时间:

Recruiting time:

From2020-08-01To 2020-09-30 

干预措施:

Interventions:

组别:

Case series

样本量:

282

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

none

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:

中性粒细胞与淋巴细胞比值

指标类型:

主要指标 

Outcome:

Neutrophil-to-lymphocyte ratio

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

淋巴结比率

指标类型:

主要指标 

Outcome:

Lymph node ratio

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:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

性别:

男性

Gender:

Male

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):

N/A

盲法:

N/A

Blinding:

N/A

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):

四川大学华西医院 http://www.cd120.com/

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

West China Hospital, Sichuan University http://www.cd120.com/

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

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

Case Record Form, CRF

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-07-10
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