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The Chinese Multi-Center Screening Trial
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注册号:

Registration number:

ChiCTR-EOC-16008456 

最近更新日期:

Date of Last Refreshed on:

2016-09-18 

注册时间:

Date of Registration:

2016-05-11 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中国宫颈癌筛查研究: 自取样HPV 检测为宫颈癌初筛方案的多中心研究 

Public title:

The Chinese Multi-Center Screening Trial  

注册题目简写:

 

English Acronym:

CHIMUST 

研究课题的正式科学名称:

中国宫颈癌筛查研究: 自取样HPV 检测为宫颈癌初筛方案的多中心研究 

Scientific title:

The Chinese Multi-Center Screening Trial: The Prevention of Cervical Cancer Using Self-collection as the Primary Screen 

研究课题代号(代码):

Study subject ID:

Study Site and Subject Number (to de-identify data) 

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:

Jerome L Belinson MD 

研究负责人:

吴瑞芳教授 

Applicant:

Jerome L Belinson MD 

Study leader:

Professor Ruifang Wu 

申请注册联系人电话:

Applicant telephone:

+86 13267241221 (CN) 

研究负责人电话:

Study leader's telephone:

+86 13827433039 

申请注册联系人传真 :

Applicant Fax:

+1 216 2248551 (USA) 

研究负责人传真:

Study leader's fax:

+86 0755-83923333-5635 

申请注册联系人电子邮件:

Applicant E-mail:

jlb@poiinc.org 

研究负责人电子邮件:

Study leader's E-mail:

wurf100@126.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

www.poiinc.org 

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:

美国俄亥俄州克利夫兰费尔蒙特大道2762号 

研究负责人通讯地址:

中国广东深圳莲花路1120号 

Applicant address:

2762 Fairmount Blvd., Cleveland Hts, OH, USA 

Study leader's address:

1120 Lianhua Rd., Dept. Ob/Gyn, Shenzhen, Futian, Guangdong, China 

申请注册联系人邮政编码:

Applicant postcode:

44118 

研究负责人邮政编码:

Study leader's postcode:

518036 

申请人所在单位:

美国克利夫兰医学中心,Lerner 医学院外科 

Applicant's institution:

Preventive Oncology International Inc. and The Cleveland Clinic  

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:

15-1549 

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:

克利夫兰临床机构伦理委员会,北京大学深圳医院伦理审查委员会 

Name of the ethic committee:

Cleveland Clinic Instituional Review Board; and Peking University Shenzhen Hospital IRM (no. PUSHGYN 2015005, 2015-10-14) 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-02-12 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

中国医学保健国际交流促进会 

Primary sponsor:

China International Exchange and Promotion Association for for Medical and Health Care  

研究实施负责(组长)单位地址:

北京海淀区知春路108号豪景大厦12层 

Primary sponsor's address:

12th Floor Haojing Bldg., 108 Xhichun Rd., Haidian, 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):

广东

市(区县):

深圳

Country:

China

Province:

Guangdong

City:

Shenzhen

单位(医院):

北京大学深圳医院

具体地址:

中国深圳莲花路1120号

Institution
hospital:

Peking University Shenzhen Hospital

Address:

1120 Lianhua Road, Futian, Shenzhen, China, 518036

经费或物资来源:

中国医学保健国际交流促进会,北京大学深圳医院 

Source(s) of funding:

China International Exchange and Promotion Association for for Medical and Health Care; Peking University Shenzhen Hospital 

研究疾病:

宫颈癌 

Target disease:

Cervical Cancer and Pre-Cancer 

研究疾病代码:

 

Target disease code:

 

研究类型:

流行病学研究 

Study type:

Epidemilogical research 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

主要目的: 评价Cobas 4800 HPV 检测技术(简称 Cobas)和 SeqHPV 检测技术自人群筛查中获取的阴道自取样本中检出宫颈高度病变(癌前病变)的效果。 次级目标: 1) 评价不同检测方法对固体(滤纸卡)、干刷、和液体样本保存转运介质的阴道自取样和医生取样样本的检测效果; 2) 评价细胞学和 Cobas4800 和 SeqHPV 检测方法初筛后,以细胞学和 HPV 亚型作为二次筛查的效果。 

Objectives of Study:

The primary objective of the project will be to evaluate the Cobas 4800 Assay, and the SeqHPV Assay for the detection of high grade pre-cancer of the uterine cervix, in population based screening samples obtained using self-collection. Secondary Objectives: 1) To evaluate differences in assay performance using solid, dry brush and liquid based specimen transport media for the self-collected specimens; 2) To evaluate cytology and genotyping as secondary screens after primary cytology and HPV screening using Cobas 4800, and SeqHPV. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

NA 

研究设计:

横断面 

Study design:

Cross-sectional 

纳入标准:

年龄 30-59 周岁,至少 3 年内没有参加过筛查,无全子宫切除手术史,无盆腔放射治疗史,未处在孕期,且同意在初筛结果显示需要时接受本项目安排的阳性者临床处理的女性。 

Inclusion criteria

Eligibility Criteria: non-pregnant, 30-59 years of age, no screening for at least 3 years, no prior hysterectomy, no prior radiation, and willing to return for positive management if indicated by the primary tests. 

排除标准:

年龄小于 30 周岁大于 59 周岁,过去 3 年内曾参加过宫颈癌筛查,有过子宫全切手术史,有过盆腔放射治疗史,或不同意在初筛结果显示需要时接受本项目安排的阳性患者处理的女性。 

Exclusion criteria:

Exclusion Criteria: Pregnant, screening in the previous 3 years, history of a hysterectomy, pelvic radiation therapy, or not willing to return for positive management if indicated by the primary tests.  

研究实施时间:

Study execute time:

From2016-07-01To 2017-06-30 

征募观察对象时间:

Recruiting time:

From2016-07-01To 2016-11-01 

干预措施:

Interventions:

组别:

选中的目标人群

样本量:

10000

Group:

Selected target population

Sample size:

干预措施:

1 次阴道自取样本和 1 次医生取样,以及对一个高危险地区筛查女性的2 次模拟自取样。任一HPV 检测结果阳性的筛查女性都将被回叫进行阴道镜检查和活检

干预措施代码:

Intervention:

1 self-sampling and 1 direct-sampling on all participants and 2 pseudo-self-sampling on participants in a high risk subset will be used for multiple assays; samples with positive test results will be followed by referral for colposcopy and biopsy.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

内蒙古自治区 

市(区县):

 

Country:

China 

Province:

Inner Mongolia Autonomous Region 

City:

Multiple (see protocol) 

单位(医院):

内蒙古自治区 

单位级别:

内蒙古自治区 

Institution
hospital:

Multiple, Inner Mongolia Autonomous Region  

Level of the institution:

Multiple 

测量指标:

Outcomes:

指标中文名:

High -Risk HPV

指标类型:

主要指标 

Outcome:

High -Risk HPV

Type:

Primary indicator 

测量时间点:

筛查

测量方法:

SEQHPV, and High -Risk HPV, respectively

Measure time point of outcome:

Screening

Measure method:

SEQHPV, and High -Risk HPV, respectively

指标中文名:

宫颈癌和癌前病变

指标类型:

主要指标 

Outcome:

Cervical Cancer and Pre-Cancer

Type:

Primary indicator 

测量时间点:

Diagnosis

测量方法:

Pathology

Measure time point of outcome:

Diagnosis

Measure method:

Pathology

指标中文名:

Specificity and Sensitivity for CIN3+ and CIN2+

指标类型:

主要指标 

Outcome:

Specificity and Sensitivity for CIN3+ and CIN2+

Type:

Primary indicator 

测量时间点:

Data Analysis

测量方法:

Statistics

Measure time point of outcome:

Data Analysis

Measure method:

Statistics

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

阴道脱落细胞

组织:

Sample Name:

cells

Tissue:

vagina

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

years (for future testing)

标本中文名:

宫颈口细胞

组织:

Sample Name:

cells

Tissue:

cervix (endocervix)

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

years (for future testing)

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 30 years
最大 Max age 59 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):

NA

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

All patients will contribute similar samples. However to eliminate collection order bias the self-collection to card specimens will be alternated in order with the self-collection to liquid samples by odd and even study ID numbers

盲法:

All subject data will be de-identified by study ID number

Blinding:

All subject data will be de-identified by study ID number

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):

After data analysis all data there will be multiple publications (public domain) and as in all of our past work, the raw data is always available for legitimate collaborative projects upon request.

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

After data analysis all data there will be multiple publications (public domain) and as in all of our past work, the raw data is always available for legitimate collaborative projects upon request.

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:

All data will be stored in the collaborative Peking University Shenzhen Hospital/Preventive Oncology International Database, designed specifically for CHIMUST. It is ID protected and kept in the Statistical Center in Shenzhen, China.

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

All data will be stored in the collaborative Peking University Shenzhen Hospital/Preventive Oncology International Database, designed specifically for CHIMUST. It is ID protected and kept in the Statistical Center in Shenzhen, China.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-05-11
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