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Prognostic factors of postoperative patients in breast cancer:an ambispective cohort study
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注册号:

Registration number:

ChiCTR2200058542 

最近更新日期:

Date of Last Refreshed on:

2022-04-12 

注册时间:

Date of Registration:

2022-04-10 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

乳腺癌患者术后预后影响因素的双向性队列研究 

Public title:

Prognostic factors of postoperative patients in breast cancer:an ambispective cohort study  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

乳腺癌患者术后预后影响因素的双向性队列研究 

Scientific title:

Prognostic factors of postoperative patients in breast cancer:an ambispective cohort study  

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:

韦所苏 

研究负责人:

杨建荣 

Applicant:

Suosu Wei 

Study leader:

Jianrong Yang 

申请注册联系人电话:

Applicant telephone:

+86 15177942970 

研究负责人电话:

Study leader's telephone:

+86 13978630882 

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:

40222503@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

1637340358@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:

广西南宁市桃源路6号广西壮族自治区人民医院教学楼12楼技术支撑部 

研究负责人通讯地址:

广西南宁市桃源路6号广西壮族自治区人民医院行政楼5楼 

Applicant address:

12th Floor,Teaching Building, Guangxi Zhuang Autonomous Region People's Hospital, No.6 Taoyuan Road ,Nanning city,Guangxi ,China 

Study leader's address:

5th Floor,Administratiom Building, Guangxi Zhuang Autonomous Region People's Hospital, No.6 Taoyuan Road ,Nanning city,Guangxi ,China 

申请注册联系人邮政编码:

Applicant postcode:

530021 

研究负责人邮政编码:

Study leader's postcode:

530021 

申请人所在单位:

广西壮族自治区人民医院 

Applicant's institution:

Guangxi Zhuang Autonomous Region People's 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:

伦理-KY-QT-202205 

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:

广西壮族自治区人民医院伦理委员会 

Name of the ethic committee:

Ethics Committee of People's Hospital of Guangxi Zhuang Autonomous Region 

伦理委员会批准日期:

Date of approved by ethic committee:

2022-03-25 

伦理委员会联系人:

易中秋、邱想英 

Contact Name of the ethic committee:

Zhongqiu Yi、Xiangying Qiu 

伦理委员会联系地址:

广西南宁市桃源路6号 

Contact Address of the ethic committee:

No.6 Taoyuan Road ,Nanning city,Guangxi 

伦理委员会联系人电话:

Contact phone of the ethic committee:

0771-5722415 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

qyylunlli@163.com 

研究实施负责(组长)单位:

广西壮族自治区人民医院 

Primary sponsor:

Zhuang Autonomous Region People's Hospital, Guangxi ,China 

研究实施负责(组长)单位地址:

广西南宁市桃源路6号 

Primary sponsor's address:

No.6 Taoyuan Road ,Nanning city,Guangxi ,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):

广西

市(区县):

南宁市

Country:

China

Province:

Guangxi

City:

Nanning city

单位(医院):

广西壮族自治区人民医院

具体地址:

青秀区桃源路6号

Institution
hospital:

Guangxi Zhuang Autonomous Region People's Hospital

Address:

No.6 Taoyuan Road ,Nanning city,Guangxi

经费或物资来源:

NA 

Source(s) of funding:

NA 

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:

A.通过建立双向性队列,观察乳腺癌患者术后远期预后与肿瘤的分型、TNM分期、年龄区间、月经状态、血常规参数、既往疾病史、肿瘤位置、腋窝前哨淋巴结转移、术后辅助治疗方案等之间的关系。 B.描述乳腺癌患者术后远期预后现况,分析乳腺癌专病的临床特征,为探讨乳腺癌远期预后影响因素提供循证医学证据。 C.通过建立回顾性队列,回顾性分析广西壮族自治区人民医院2013年1月至2022年1月经过病理学确诊为乳腺癌并按乳腺癌诊疗指南行手术治疗的患者。 D.通过建立前瞻性队列研究,前瞻性观察乳腺癌术后患者远期乳腺专病外疾病的发病率,并收集相关的影响因素。 

Objectives of Study:

A. through the establishment of bidirectional queue, observe the long-term prognosis of postoperative breast cancer patients with tumor classification, TNM stage, age range, and state of menstruation, blood is often. B. describe the status of long-term prognosis of postoperative breast cancer patients, and analyze the clinical features of breast cancer ZhuanBing, to explore factors affecting long-term prognosis of breast cancer to provide evidence-based medicine. C. by establishing retrospective cohort, a retrospective analysis of the guangxi zhuang autonomous region people's hospital between January 2013 and January 2022 after pathology diagnosis. D. by establishing a prospective cohort study, prospective observation of postoperative breast cancer patients after breast ZhuanBing outside disease incidence, and collect the related influencing factors. 

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)回顾性研究广西壮族自治区人民医院2013年1月至2022年1月经过病理学确诊为乳腺癌并按乳腺癌诊疗指南行手术治疗的患者。 2)所有患者采集标本前均未经历化疗、放疗以及内分泌治疗等; 3)无甲亢、类风湿、糖尿病等自身免疫性疾病; 4)无血液系统疾病; 5)无类固醇药物治疗史; 6)患者意识清醒,生命体征平稳。 

Inclusion criteria

1) retrospective study of the guangxi zhuang autonomous region people's hospital between January 2013 and January 2022 through the pathological diagnosis of mammary gland 2) all of the patients has not been collecting specimens before undergoing chemotherapy, radiotherapy and endocrine therapy, etc. 3) no hyperthyroidism, rheumatoid disease, autoimmune diseases such as diabetes 4) no blood system diseases 5) there is no history of steroid therapy 6) in patients with conscious, the stable vital signs. 

排除标准:

1)患者意识不清醒,生命体征不平稳的患者; 2)妊娠或哺乳期妇女; 3)合并心、肝、肾、造血系统和内分泌系统等严重原发性疾病、其他恶性肿瘤精神病患者。 4)失访、术后随访无任何检测记录者。 5)患者拒绝签署知情同意书或无法完成接受随访; 6)研究者认为不适合入组的其他情况。 

Exclusion criteria:

1) the patient is not conscious, patients with stable vital signs are not 2) pregnancy or breast-feeding women 3) merge heart, liver, kidney, hematopoietic system, endocrine system and so on serious primary diseases, other malignant tumor psychiatric patients. 4) lost to follow-up, postoperative follow-up without any testing 5) patients refused to sign the informed consent or cannot complete follow-up 6) the researchers think the other condition that doesn't fit into the group. 

研究实施时间:

Study execute time:

From2022-05-15To 2026-12-31 

征募观察对象时间:

Recruiting time:

From2022-05-15To 2025-12-31 

干预措施:

Interventions:

组别:

乳腺癌患者术后预后影响因素

样本量:

1000

Group:

Prognostic factors affecting postoperative mortality in patients with breast cancer

Sample size:

干预措施:

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):

广西 

市(区县):

南宁市 

Country:

China 

Province:

Guangxi 

City:

Nanning city 

单位(医院):

广西壮族自治区人民医院 

单位级别:

三级 

Institution
hospital:

Guangxi Zhuang Autonomous Region People's Hospital  

Level of the institution:

Tertiary 

测量指标:

Outcomes:

指标中文名:

乳腺癌患者术后预后影响因素

指标类型:

主要指标 

Outcome:

Type:

Primary indicator 

测量时间点:

测量方法:

病理检查、影像学检查、实验室检查、临床诊断。

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:

乳房癌组织、癌旁组织

Sample Name:

Blood

Tissue:

Breast

人体标本去向

使用后销毁 

说明

2年

Fate of sample:

Destruction after use 

Note:

2years

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 18 years
最大 Max age 100 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):

无需随机

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

Not used

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

Yes

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):

论文发表后通过发送信息至作者邮箱获取,邮箱地址:40222503@qq.com

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

Obtained by sending email, 40222503@qq.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:

利用医院的大数据平台建立数据库(CRF),所有数据均保留原始数据以备核查,以保证数据的真实性和可溯源性。全部患者完成随访、数据质询获得解决并通过审核后锁定数据库,用于统计分析。 1、数据管理 1)数据录入 有专人管理数据库,通过医院大数据平台抽取进入CRF表,管理员根据受试者的原始观察记录,将数据及时、完整、正确、清晰地载入病例报告表。 2)数据核查 数据管理员定期随机抽取CRF患者的数据,并与医院数据系统进行匹配核对,写出数据库检查报告,其内容包括研究完成情况(含脱落受试者清单)、入选/排除标准检查、完整性检查、逻辑一致性检查、离群数据检查、时间窗检查、不良事件检查等。通过后,数据库将被锁定。 3)数据存档 数据存档文件包括数据库、检查程序、分析程序、分析结果、编码本和说明文件等,应分类保存,并有多个备份保存于不同磁盘或记录介质上,妥善保存,防止损坏。

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

Using the hospital built big data platform, database (CRF), all data are retained the original data for verification, to ensure the authenticity of the data and can be traced back. 1, the data management 1) data entry Are personnel management database, enter the CRF through hospital big data platform to extract tables, administrator according to the subjects' original observation records, the data in a timely manner, to the end. 2) data for verification Data, data managers regularly random CRF patients and matched with hospital data system check, write inspection report database, including its content. 3) data archive Data archive file including the database, check the program and analysis program, the results of the analysis, coding and documents, etc., shall be stored in classification, and have more than one backup

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2022-04-10
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