Today is 2020-08-05

Estimation of trend and burden of HPV-associated non-cervical cancer in China: a population-based study
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注册号:

Registration number:

ChiCTR2000032262 

最近更新日期:

Date of Last Refreshed on:

2020-04-26 

注册时间:

Date of Registration:

2020-04-24 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中国HPV感染相关非宫颈部位肿瘤的疾病负担及趋势分析:一项人群为基础的研究 

Public title:

Estimation of trend and burden of HPV-associated non-cervical cancer in China: a population-based study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中国HPV感染相关非宫颈部位肿瘤的疾病负担及趋势分析:一项人群为基础的研究 

Scientific title:

Estimation of trend and burden of HPV-associated non-cervical cancer in China: a population-based 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:

赵方辉 

研究负责人:

赵方辉 

Applicant:

Fanghui Zhao 

Study leader:

Fanghui Zhao 

申请注册联系人电话:

Applicant telephone:

+86 10 87788900 

研究负责人电话:

Study leader's telephone:

+86 10 87788900 

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:

zhaofangh@cicams.ac.cn 

研究负责人电子邮件:

Study leader's E-mail:

zhaofangh@cicams.ac.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:

北京市朝阳区潘家园南里17号 

研究负责人通讯地址:

北京市朝阳区潘家园南里17号 

Applicant address:

17 Panjiayuan Lane South, Chaoyang District, Beijing, China 

Study leader's address:

17 Panjiayuan Lane South, Chaoyang District, Beijing, 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:

国家癌症中心/中国医学科学院北京协和医学院肿瘤医院 

Applicant's institution:

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College 

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:

20/041-2237 

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:

国家癌症中心/中国医学科学院北京协和医学院肿瘤医院伦理委员会 

Name of the ethic committee:

Ethics Committee of National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-03-06 

伦理委员会联系人:

吴大维 

Contact Name of the ethic committee:

Wu Dawei 

伦理委员会联系地址:

北京市朝阳区潘家园南里17号 

Contact Address of the ethic committee:

17 Panjiayuan Lane South, Chaoyang District, Beijing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 10-87788495 

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:

国家癌症中心/中国医学科学院北京协和医学院肿瘤医院 

Primary sponsor:

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College 

研究实施负责(组长)单位地址:

北京市朝阳区潘家园南里17号 

Primary sponsor's address:

17 Panjiayuan Lane South, Chaoyang 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):

国家癌症中心/中国医学科学院北京协和医学院肿瘤医院

具体地址:

北京市朝阳区潘家园南里17号

Institution
hospital:

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Address:

17 South Panjiayuan Lane, Beijing 100021, China

经费或物资来源:

默沙东(中国)投资有限公司 

Source(s) of funding:

MSD China Holding Co., Ltd 

研究疾病:

外阴癌、阴道癌、阴茎癌、肛门癌、口咽癌、口腔癌、喉癌 

Target disease:

Vulvar cancer, vaginal cancer, penile cancer, anal cancer, oropharyngeal cancer, oral cancer, laryngeal 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:

1)分析不同性别、年龄和地区HPV相关非宫颈部位肿瘤负担 2)分析HPV相关非宫颈部位肿瘤近十年发病趋势 3)初步评估HPV相关非宫颈部位肿瘤诊疗的成本效益 

Objectives of Study:

1.To estimate HPV-attributable non-cervical cancer cases and deaths by site, sex and region; 2.To assess the long-term trends of age-standardized cancer incidence and mortality rate; 3.To evaluate the cost-effectiveness of treatment of HPV-attributable non-cervical cancers.  

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:

2017年1月1日至2019年12月31日期间,选取肿瘤医院确诊的外阴癌、阴道癌、阴茎癌、肛门癌、口咽癌、口腔癌和喉癌病例  

Inclusion criteria

From January 1, 2017 to December 31, 2019, vulvar cancer, vaginal cancer, penile cancer, anal cancer, oropharyngeal cancer, oral cancer and throat cancer cases confirmed by cancer hospital 

排除标准:

合并其他原发性恶性肿瘤或严重内科合并症 

Exclusion criteria:

Patients with other primary malignant tumors or serious medical complications 

研究实施时间:

Study execute time:

From2020-01-01To 2021-12-31 

征募观察对象时间:

Recruiting time:

From2020-08-01To 2021-06-30 

干预措施:

Interventions:

组别:

Case series

样本量:

700

Group:

Case series

Sample size:

干预措施:

NA

干预措施代码:

Intervention:

NA

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

HPV相关非宫颈部位肿瘤

指标类型:

主要指标 

Outcome:

HPV related tumors in non-cervical areas

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肿瘤负担

指标类型:

主要指标 

Outcome:

tumor burden

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

成本-效益

指标类型:

次要指标 

Outcome:

Cost-effect

Type:

Secondary 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:

No

组织:

Sample Name:

No

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 1 years
最大 Max age 99 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):

NA

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 ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

Not stated

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

Not stated

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:

问卷调查所收集的信息来自医院信息管理系统及患者本人/家属的报告。

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

Data collected in the questionnaire is from the hospital information management system and the report of the patient himself/her family.

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-04-24
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