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Molecular epidemiology study of cervical cancer in Wudu of Gansu province
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注册号:

Registration number:

ChiCTR1800016405 

最近更新日期:

Date of Last Refreshed on:

2018-05-31 

注册时间:

Date of Registration:

2018-05-31 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

甘肃武都宫颈癌分子流行病学研究 

Public title:

Molecular epidemiology study of cervical cancer in Wudu of Gansu province 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

全球宫颈癌死亡率最高区-甘肃武都宫颈癌人乳头状瘤病毒型别、基因表达及其与DNA 损伤修复蛋白的关系 

Scientific title:

The relationship of HPV genetype, gene expression and DNA damage proteins in Wudu of Gansu province, the highest rate of cervical cancer mortality in the world 

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:

郭忠 

研究负责人:

赵晋 

Applicant:

Zhong Guo 

Study leader:

JIn Zhao 

申请注册联系人电话:

Applicant telephone:

+86 18709405906 

研究负责人电话:

Study leader's telephone:

+86 13893629506 

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:

gz6768@163.com 

研究负责人电子邮件:

Study leader's E-mail:

yxzj@xbmu.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:

甘肃省兰州市城关区西北新村1号 

研究负责人通讯地址:

甘肃省兰州市城关区西北新村1号 

Applicant address:

1 Xibeixincun, Lanzhou, Gansu, China 

Study leader's address:

1 Xibeixincun, Lanzhou, Gansu, China 

申请注册联系人邮政编码:

Applicant postcode:

730030 

研究负责人邮政编码:

Study leader's postcode:

730030 

申请人所在单位:

西北民族大学 

Applicant's institution:

Northwest Minzu 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:

2012-0019 

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:

西北民族大学伦理委员会 

Name of the ethic committee:

Ethics Committee of Northwest Minzu University 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

赵晋 

Contact Name of the ethic committee:

Jin Zhao 

伦理委员会联系地址:

甘肃省兰州市西北新村一号西北民族大学医学院 

Contact Address of the ethic committee:

The medical college of Northwest Minzu University, 1 Xibeixincun, Lanzhou, Gansu, 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:

西北民族大学医学院 

Primary sponsor:

Medical College of Northwest Minzu University 

研究实施负责(组长)单位地址:

甘肃省兰州市城关区西北新村1号,西北民族大学医学院 

Primary sponsor's address:

1 Xibeixincun, Lanzhou, Gansu, 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):

甘肃省

市(区县):

兰州市

Country:

China

Province:

Gansu Province

City:

Lanzhou City

单位(医院):

西北民族大学医学院

具体地址:

甘肃省兰州市城关区西北新村1号

Institution
hospital:

Medical College of Northwest Minzu University

Address:

1 Xibeixincun, Lanzhou, Gansu, China

国家:

中国

省(直辖市):

甘肃省

市(区县):

兰州市

Country:

China

Province:

Gansu Province

City:

Lanzhou City

单位(医院):

甘肃省肿瘤医院

具体地址:

Institution
hospital:

Gansu Provincial Cancer Hospital

Address:

国家:

中国

省(直辖市):

甘肃省

市(区县):

陇南市

Country:

China

Province:

Gansu

City:

Longnan

单位(医院):

陇南市第一人民医院

具体地址:

甘肃省陇南市武都区东江镇5号路

Institution
hospital:

1st Hospital of Longnan City

Address:

5 Dongjiang, Wudu

经费或物资来源:

国家自然科学基金 

Source(s) of funding:

the National Natural Science Foundation of China 

研究疾病:

宫颈癌 

Target disease:

Cervical Cancer 

研究疾病代码:

C53.9 

Target disease code:

C53.9 

研究类型:

基础科学研究 

Study type:

Basic science 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

甘肃省陇南市武都区宫颈癌妇女死亡率为36.15/10万,居世界最高水平,原因不清。该研究探讨该地区宫颈癌高死亡率发生的原因,为发现和确定宫颈癌高危人群、研究宫颈癌的发病机制以及宫颈癌疫苗研制提供重要的理论依据。 

Objectives of Study:

The death rate of cervical cancer in Wudu Area of Longnan city of Gansu province is 36.15 among 100,000 women on average and that is the highest level in the world, but the reason is unclear. This research aimed to investigate the causes of the high death rate of the cervical cancer in Wudu Area and supply theoretically basis to determinate the high risk group of cervical cancer, to study the pathogenesis and to develop a suitable vaccine of cervical cancer. 

药物成份或治疗方案详述:

用人乳头状瘤病毒(HPV)基因微阵列分型、实时荧光定量PCR和免疫组化等方法检测宫颈组织中HPV型别、高危型HPV E6/E7 的转录及DNA双链损伤(DSB)修复蛋白的表达,探讨武都宫颈癌和癌前病变发病相关的主要HPV型别、高危型HPV E6/E7 mRNA表达与宫颈癌发病之间的关系及高危型HPV E6/E7mRNA表达与DSB修复蛋白表达之间的关系。 

Description for medicine or protocol of treatment in detail:

In this research, subtype of human papilloma virus (HPV), transcription of high risk HPV E6/E7 and expression of DNA double strand break(DSB) repair proteins are detected with methods of HPV gene microarray, fluorescence quantitative PCR and immunohistochemisty in biopsies of cervicitis, cervical intraepithelial neoplasia and cervical cancer coming from patients of Wudu Area. The aim is to discuss the main HPV subtype related to premalignant lesions and cervical cancer of Wudu Area and to conduct research on the relationships between the expression of HPV E6/E7 mRNA and cervical carcinogenesis and the expression of HPV E6/E7 mRNA and DSB repair proteins.  

研究设计:

随机抽样 

Study design:

Randomly Sampling 

纳入标准:

本项目以武都宫颈炎、宫颈上皮内瘤变(CIN)及宫颈癌患者和甘肃省其它地区宫颈癌患者标本为研究对象。 

Inclusion criteria

The biopsies of cervicitis, cervical intraepithelial neoplasia and cervical cancer coming from patients of Wudu Area and cervical cancer coming from other areas of Gansu was been researched.  

排除标准:

未接受放化疗和其它治疗 

Exclusion criteria:

No radiotherapy and chemotherapy or other treatment 

研究实施时间:

Study execute time:

From2013-01-01To 2016-12-31 

干预措施:

Interventions:

组别:

慢性宫颈炎、CIN,宫颈癌

样本量:

470

Group:

cervicitis, cervical intraepithelial neoplasia and cervical cancer

Sample size:

干预措施:

干预措施代码:

Intervention:

No

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

甘肃 

市(区县):

 

Country:

China 

Province:

Gansu 

City:

 

单位(医院):

甘肃省肿瘤医院 

单位级别:

三级甲等 

Institution
hospital:

Gansu Provical Cancer Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

甘肃 

市(区县):

陇南市 

Country:

China 

Province:

Gansu 

City:

Longnan 

单位(医院):

陇南市第一人民医院 

单位级别:

三级乙等 

Institution
hospital:

1st Hospital of Longnan City  

Level of the institution:

Tertiary B Hospital 

测量指标:

Outcomes:

指标中文名:

HPV型别

指标类型:

主要指标 

Outcome:

HPV genetype

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

HPVmRNA

指标类型:

主要指标 

Outcome:

HPVmRNA

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

DNA损伤蛋白标记

指标类型:

主要指标 

Outcome:

The marker of DNA damage

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:

宫颈活检标本

组织:

Sample Name:

Cervical biopsis

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:

结束

Completed

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):

妇科医生获取门诊就诊病人活检标本

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

Obtaining biopsy specimens from out-patient patients by gynecologists

盲法:

Blinding:

试验完成后的统计结果(上传文件):

点击下载

Calculated Results ater
the Study Completed(upload file):

download

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):

2020年1月1号

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

Janary 1, 2020

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:

病理记录表

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

Case Record Form

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2018-05-31
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