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The value of multi-target fecal FIT-DNA combined detection technology on colorectal Neoplastic lesions
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注册号:

Registration number:

ChiCTR2200060076 

最近更新日期:

Date of Last Refreshed on:

2022-05-18 

注册时间:

Date of Registration:

2022-05-18 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

多靶点粪便FIT-DNA联合检测在结直肠肿瘤性病变中的应用评估 

Public title:

The value of multi-target fecal FIT-DNA combined detection technology on colorectal Neoplastic lesions 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

多靶点粪便FIT-DNA联合检测在结直肠肿瘤性病变中的应用评估 

Scientific title:

The value of multi-target fecal FIT-DNA combined detection technology on colorectal Neoplastic lesions 

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:

宾楚轩 

研究负责人:

宾楚轩 

Applicant:

Chuxuan Bin 

Study leader:

Chuxuan Bin 

申请注册联系人电话:

Applicant telephone:

13699212303 

研究负责人电话:

Study leader's telephone:

13699212303 

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:

binchuxuan@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

binchuxuan@hotmail.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:

北京市经济技术开发区西环南路2号北京同仁医院内镜中心 

研究负责人通讯地址:

北京市经济技术开发区西环南路2号北京同仁医院内镜中心 

Applicant address:

Endoscopy Center,Beijing Tongren Hospital,No.2 xihuan south road, economic&technology development area, Beijing 

Study leader's address:

Endoscopy Center,Beijing Tongren Hospital,No.2 xihuan south road, economic&technology development area, Beijing 

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:

首都医科大学附属北京同仁医院 

Applicant's institution:

Beijing Tongren Hospital, Capital Medical 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:

TRECKY2021-141 

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:

首都医科大学附属北京同仁医院伦理委员会 

Name of the ethic committee:

Ethics Committee, Beijing Tongren Hospital, Capital Medical University 

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:

常灏 

Contact Name of the ethic committee:

Hao Chang 

伦理委员会联系地址:

北京市东城区东交民巷1号 

Contact Address of the ethic committee:

No.1 Dongjiaominxiang, Dongcheng district, Beijing ,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:

首都医科大学附属北京同仁医院 

Primary sponsor:

Beijing Tongren Hospital, Capital Medical University 

研究实施负责(组长)单位地址:

北京市经济技术开发区西环南路2号北京同仁医院内镜中心 

Primary sponsor's address:

Endoscopy Center,Beijing Tongren Hospital,No.2 xihuan south road, Economic&Technology development area, Beijing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

自筹 

Source(s) of funding:

self-finance 

研究疾病:

结直肠癌 

Target disease:

colonrectal cancer 

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:

其它 

Study phase:

N/A 

研究目的:

以结肠镜及病理活检结果为金标准,验证评估多靶点粪便FIT-DNA联合检测技术对预测结直肠癌及进展期腺瘤的临床应用价值。 

Objectives of Study:

Using colonoscopy and pathological biopsy results as the gold standard, to verify and evaluate the clinical application value of FIT-DNA technology in predicting colorectal cancer 

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)年龄18-70岁之间。 (2)肠镜发现结直肠肿瘤,且病理为癌、腺瘤的患者。 

Inclusion criteria

1) Age between 18-70 years old. (2) Patients with colorectal tumor found by colonoscopy, and the pathology is cancer or adenoma. 

排除标准:

1)合并其他系统恶性肿瘤的患者。 (2)存在肠镜检查禁忌症的患者。 (3)结肠肿瘤经病理证实非癌或腺瘤的患者。 

Exclusion criteria:

1) Patients with malignant tumors of other systems. (2) Patients with contraindications to colonoscopy. (3) Patients with colon tumors confirmed by pathology as non-cancer or adenoma. 

研究实施时间:

Study execute time:

From2022-06-01To 2022-10-31 

征募观察对象时间:

Recruiting time:

From2022-06-01To 2022-10-31 

诊断措施:

Diagnostic measures:

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):

结肠镜及病理活检

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):

colonoscopy and pathological biopsy

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):

多靶点粪便FIT-DNA联合检测技术

Index test:

FIT-DNA technology

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)

结直肠癌

例数:

Sample size:

35

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):

colorectal tumor

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):

腺瘤和正常人

例数:

Sample size:

70

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

adenoma and normal people

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

灵敏度

指标类型:

主要指标 

Outcome:

Sensitivity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

特异度

指标类型:

主要指标 

Outcome:

specificity

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:

粪便

组织:

Sample Name:

stool

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 70 years

性别:

男性

Gender:

Male

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:

Not stated

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

No

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):

no

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

no

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:

病例记录表

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

Case Record Form

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2022-05-18
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