Today is 2019-12-10

Establishment of thyroid cancer case information database and epidemiological investigation
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注册号:

Registration number:

ChiCTR1900027169 

最近更新日期:

Date of Last Refreshed on:

2019-11-03 

注册时间:

Date of Registration:

2019-11-03 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

甲状腺癌病例信息数据库建立与流行病学调查 

Public title:

Establishment of thyroid cancer case information database and epidemiological investigation 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

甲状腺癌大数据的真实世界研究 

Scientific title:

A real-world study of big data on thyroid cancer 

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:

李健明 

研究负责人:

钱林学 

Applicant:

Li Jianming 

Study leader:

Qian Linxue 

申请注册联系人电话:

Applicant telephone:

+86 18810611944 

研究负责人电话:

Study leader's telephone:

+86 13311100999 

申请注册联系人传真 :

Applicant Fax:

+86 010 63138576 

研究负责人传真:

Study leader's fax:

+86 010 63138576 

申请注册联系人电子邮件:

Applicant E-mail:

lijianming@ccmu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

qianlinxue2002@163.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:

北京市西城区永安路95号 

研究负责人通讯地址:

北京市西城区永安路95号 

Applicant address:

95 Yong'an Road, Xicheng District, Beijing, China 

Study leader's address:

95 Yong'an Road, Xicheng District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100000 

研究负责人邮政编码:

Study leader's postcode:

100000 

申请人所在单位:

北京友谊医院 

Applicant's institution:

Beijing Friendship 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:

2019-P2-159-01 

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:

首都医科大学附属北京友谊医院生命伦理委员会 

Name of the ethic committee:

Life ethics committee of Beijing friendship hospital, Capital medical university 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-08-29 

伦理委员会联系人:

崔焱 

Contact Name of the ethic committee:

Yan Cui 

伦理委员会联系地址:

北京市西城区永安路95号 

Contact Address of the ethic committee:

95 Yong'an Road, Xicheng District, Beijing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 13661202501 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

13661202501@163.com 

研究实施负责(组长)单位:

首都医科大学附属北京友谊医院 

Primary sponsor:

Beijing Friendship Hospital, Captial Medical University 

研究实施负责(组长)单位地址:

北京市西城区永安路95号 

Primary sponsor's address:

95 Yong'an Road, Xicheng District, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京友谊医院

具体地址:

西城区永安路95号

Institution
hospital:

Beijing Friendship Hospital, Captial Medical University

Address:

95 Yong'an Road, Xicheng District

经费或物资来源:

北京市医管局登峰人才计划 

Source(s) of funding:

Beijing Municipal Administration of the Hospitals’ Ascent Plan 

研究疾病:

甲状腺癌 

Target disease:

thyroid carcinoma 

研究疾病代码:

 

Target disease code:

 

研究类型:

卫生服务研究 

Study type:

Health Services Research 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

(1)建立甲状腺癌临床数据库,探究甲状腺癌术前、术后及手术方式等因素历年的变化趋势。 (2)基于甲状腺癌临床数据库,探究甲状腺癌相关多因素与预后间关系。 

Objectives of Study:

(1) Establish a thyroid cancer clinical database, and explore the changing trend of factors such as preoperative, postoperative and surgical methods of thyroid cancer over the years. (2) Based on the clinical database of thyroid cancer, explore the relationship between thyroid cancer-related factors and prognosis. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

(1)病理学证实甲状腺癌; (2)患者有完整的病例记录; (3)患者均有随访信息; 

Inclusion criteria

(1) Pathologically confirmed thyroid cancer; (2) Te patient has a complete case record; (3) All patients had follow-up information; 

排除标准:

无 

Exclusion criteria:

No exclusion criteria. 

研究实施时间:

Study execute time:

From2019-11-07To 2020-08-01 

干预措施:

Interventions:

组别:

甲状腺癌远处转移组与非远处转移组

样本量:

5000

Group:

Distant metastasis group and non-distant metastasis group of thyroid carcinoma

Sample size:

干预措施:

外科手术

干预措施代码:

Intervention:

Surgery

Intervention code:

组别:

甲状腺癌原发复发组与非复发组

样本量:

5000

Group:

Thyroid cancer recurrence group and non-recurrence group

Sample size:

干预措施:

外科手术

干预措施代码:

Intervention:

Surgery

Intervention code:

组别:

甲状腺癌归因死亡组与非死亡组

样本量:

5000

Group:

Thyroid cancer of death group and the non-death group

Sample size:

干预措施:

外科手术

干预措施代码:

Intervention:

surgery

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京友谊医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Friendship Hospital, Captial Medical University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京大学附属第三临床医院 

单位级别:

三级甲等 

Institution
hospital:

The Third Affiliated Clinical hospital of Peking University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国人民解放军总医院 

单位级别:

三级甲等 

Institution
hospital:

General Hospital of the People's Liberation Army  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

颈部超声

指标类型:

主要指标 

Outcome:

Ultrasound

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

病理

指标类型:

主要指标 

Outcome:

Pathology

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 3 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):

从历史随访期间,筛选出甲状腺癌原位复发、远处转移及死亡的患者;采用倾向得分匹配法,从非甲状腺癌原位复发、远处转移及死亡的患者中选出对照组。

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

During historical follow-up,Patients with in situ recurrence, distant metastasis and death of thyroid cancer were screened out. The control group was selected by propensity score matching.

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):

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):

临床试验公共管理平台, http://www.medresman.org.cn.

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

Clinical Trial Management Public Platform, http://www.medresman.org.cn.

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:

电子采集和管理系统

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

Electronic Data Capture, EDC

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-11-03
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