今天是:2019-05-24 星期五

多种小分子诊断标记物联合检测在宫颈癌筛查中的应用
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注册号:

Registration number:

ChiCTR1900023180 

最近更新日期:

Date of Last Refreshed on:

2019-05-15 

注册时间:

Date of Registration:

2019-05-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

多种小分子诊断标记物联合检测在宫颈癌筛查中的应用 

Public title:

The screening value of combined measurement of multiple serum tumor markers in cervical cancer 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

多种小分子诊断标记物联合检测在宫颈癌筛查中的应用 

Scientific title:

The screening value of combined measurement of multiple serum tumor markers in cervical 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:

刘光泉 

研究负责人:

刘光泉 

Applicant:

Liu Guangquan 

Study leader:

Liu Guangquan 

申请注册联系人电话:

Applicant telephone:

+86 18994080535 

研究负责人电话:

Study leader's telephone:

+86 18994080535 

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:

w467205559@126.com 

研究负责人电子邮件:

Study leader's E-mail:

w467205559@126.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:

江苏省南京市石鼓路天妃巷123号 

研究负责人通讯地址:

江苏省南京市石鼓路天妃巷123号 

Applicant address:

123 Tianfei Lane, Shigu Road, Nanjing, Jiangsu, China 

Study leader's address:

123 Tianfei Lane, Shigu Road, Nanjing, Jiangsu, 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:

南京市妇幼保健院 

Applicant's institution:

Nanjing Maternity and Child Health Hospital 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

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:

南京市妇幼保健院 

Primary sponsor:

Nanjing Maternity and Child Health Hospital 

研究实施负责(组长)单位地址:

江苏省南京市石鼓路天妃巷123号 

Primary sponsor's address:

123 Tianfei Lane, Shigu Road, Nanjing, Jiangsu, 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):

江苏

市(区县):

Country:

China

Province:

Jiangsu

City:

单位(医院):

南京市妇幼保健院

具体地址:

江苏省南京市石鼓路天妃巷123号

Institution
hospital:

Nanjing Maternity and Child Health Hospital

Address:

123 Tianfei Lane, Shigu Road, Nanjing, Jiangsu

经费或物资来源:

南京医科大学科技发展基金,南京市医学科技发展项目  

Source(s) of funding:

Science and Technology Development Fund of Nanjing Medical University, Nanjing Medical Science and Technology Development Project  

研究疾病:

宫颈鳞状细胞癌 

Target disease:

Cervical squamous cell carcinoma 

研究疾病代码:

 

Target disease code:

 

研究类型:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

通过回顾性研究检验多种小分子标记物联合检测在宫颈鳞状细胞癌筛查中的应用。进而提升宫颈癌检出率,尽可能的做到早诊断、早治疗,改善宫颈癌患者预后。 

Objectives of Study:

The purpose of this retrospective study was to examine the application of combined detection of multiple small molecular markers in cervical squamous cell carcinoma screening. And then improve the prognosis of patient with cervical squamous cell carcinoma by early diagnosis and early treatment. 

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:

病理诊断明确的宫颈鳞状细胞癌患者。 

Inclusion criteria

cervical squamous cell carcinoma patient confirmed by pathological examination. 

排除标准:

1,妊娠女性; 2,合并影响凝血功能疾病; 3,伴有任何部位感染的; 4,肝功能异常,谷丙转氨酶或谷草转氨酶升高大于正常三倍异常; 5,血压或血糖控制不佳; 

Exclusion criteria:

1. Pregnant women; 2. coagulation disorders; 3. Infection at any site; 4. Liver function was abnormal, the increase of alanine aminotransferase or glutamic oxaloacetic aminotransferase was more than three times of normal; 5. Poor control of blood pressure or blood sugar. 

研究实施时间:

Study execute time:

From2019-06-01To 2019-12-31 

诊断试验:

Diagnostic Tests:

金标准或参考标准(即可准确诊断某疾病的单项方法或多项联合方法,在本研究中用于诊断是否有该病的临床参考标准):

病理学诊断

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

Pathological examination

指标试验(即本研究的待评估诊断试验,无论为方法、生物标志物或设备,均请列出名称):

多种小分子标记物联合检测

Index test:

multiple small molecular markers

目标人群(可以是某种疾病患者或正常人群,详细描述其疾病特征,注意应纳入符合分布特点的全序列病例,具有良好的代表性)

宫颈鳞状细胞癌患者

例数:

Sample size:

100

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

cervical squamous cell carcinoma patient

容易混淆的疾病人群(即与目标疾病不易区分的一种或多种不同疾病,应避免采用正常人群对照的病例-对照设计):

例数:

Sample size:

0

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

南京市妇幼保健院 

单位级别:

三级甲等 

Institution
hospital:

Nanjing Maternity and Child Health Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

受试者工作特征曲线

指标类型:

主要指标 

Outcome:

Receiver operating characteristic curve

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

敏感性

指标类型:

次要指标 

Outcome:

Sensitivity

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

特异性

指标类型:

次要指标 

Outcome:

Specificity

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

约登指数

指标类型:

次要指标 

Outcome:

Yoden index

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:

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 10 years
最大 Max age 80 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):

N/A

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

N/A

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/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):

通过期刊杂志发表

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

published in journals or magazines

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:

住院和门诊病历系统

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

medical record system of inpatient and outpatient

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-05-15
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