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克罗恩病早期诊断的队列建立与临床标志物的组学研究
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注册号:

Registration number:

ChiCTR1900022728 

最近更新日期:

Date of Last Refreshed on:

2019-04-23 

注册时间:

Date of Registration:

2019-04-23 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

克罗恩病早期诊断的队列建立与临床标志物的组学研究 

Public title:

Cohort study combined with omics screening for the early diagnostic markers in Crohn's disease 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

克罗恩病早期诊断的队列建立与临床标志物的组学研究 

Scientific title:

Cohort study combined with omics screening for the early diagnostic markers in Crohn's disease 

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:

陆晓娟 

研究负责人:

盛剑秋 

Applicant:

Xiaojuan Lu 

Study leader:

Jianqiu Sheng 

申请注册联系人电话:

Applicant telephone:

+86 13810376983 

研究负责人电话:

Study leader's telephone:

+86 13601187561 

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:

valleyluxj@126.com 

研究负责人电子邮件:

Study leader's E-mail:

jianqiu@263.net 

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:

北京市东城区南门仓胡同5号 

研究负责人通讯地址:

北京市东城区南门仓胡同5号 

Applicant address:

5 Nan-Men-Cang Hutong, Dongcheng District, Beijing, China 

Study leader's address:

5 Nan-Men-Cang Hutong, Dongcheng 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:

中国人民解放军总医院第七医学中心(原陆军总医院) 

Applicant's institution:

The 7th Medical Center of the PLA General Hospital (Army general hospital) 

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:

2017-46 

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:

中国人民解放军总医院第七医学中心(原陆军总医院)伦理委员会 

Name of the ethic committee:

The 7th Medical Center of the PLA General Hospital (Army general hospital) ethics committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-08-14 

伦理委员会联系人:

中国人民解放军总医院第七医学中心(原陆军总医院)伦理委员会 

Contact Name of the ethic committee:

The 7th Medical Center of the PLA General Hospital (Army general hospital) ethics committee 

伦理委员会联系地址:

北京市东城区南门仓胡同5号 

Contact Address of the ethic committee:

5 Nan-Men-Cang Hutong, 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:

中国人民解放军总医院第七医学中心(原陆军总医院) 

Primary sponsor:

The 7th Medical Center of the PLA General Hospital (Army general hospital) 

研究实施负责(组长)单位地址:

北京市东城区南门仓胡同5号 

Primary sponsor's address:

5 Nan-Men-Cang Hutong, Dongcheng 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):

中国人民解放军总医院第七医学中心(原陆军总医院)

具体地址:

北京市东城区南门仓胡同5号

Institution
hospital:

The 7th medical center of the PLA general hospital(Army general hospital )ethics committee

Address:

5 Nan-Men-Cang Hutong, Dongcheng District, Beijing, China

经费或物资来源:

北京市卫生和计划生育委员会 

Source(s) of funding:

Beijing health and family planning commission 

研究疾病:

克罗恩病 

Target disease:

Crohn's disease 

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:

1.完善亚临床期/早期CD的筛查、随访流程,建立亚临床期/早期CD患者队列及生物样本库。 2.明确多种血清标志物联合检测亚临床期/早期CD的最佳组合方式及检测性能,总结归纳亚临床期/早期CD的内镜、影像学和组织病理学特征。 3.探索亚临床期/早期CD的肠道微生物和代谢组学特征性改变,寻找新的诊断方法和标志物。 4.建立适合临床推广的CD的早期诊断方法。 

Objectives of Study:

1. Improve the screening and follow-up procedures of subclinical/early CD, and establish a subclinical/early CD patient cohort and biological sample bank; 2. To determine the optimal combination and detection performance of multiple serum markers combined with subclinical/early CD, and to summarize the endoscopic, imaging and histopathological features of subclinical/early CD; 3.To explore the intestinal microbial and metabolomic characteristics of subclinical stage/early CD, and to find new diagnostic methods and markers; 4. Establish an early diagnostic method for CDs that are suitable for clinical promotion. 

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:

具备CD高危条件之一的患者,均接受结肠镜检查,一旦发现回肠末端或结肠不同部位的单发或多发表浅小溃疡、糜烂患者,则确定入组排查和随访。 CD高危条件包括:不明原因的顽固性慢性腹痛并伴有排便习惯改变的患者(包括腹泻、便秘);阑尾炎术后右下腹疼痛不缓解者;无原因的频繁口腔溃疡患者;不明原因的皮肤、关节病变患者;一级血缘亲属患有IBD者;健康体检发现回肠末端或结肠不同部位存在单发或多发阿弗它溃疡的患者。 

Inclusion criteria

Patients with one of the high-risk conditions of CD were examined by colonoscopy. Once a single or multiple patients with shallow ulcers or erosions were found at the end of the ileum or in different parts of the colon, enrollment and follow-up were determined. High-risk conditions of CD including: patients with unexplained refractory chronic abdominal pain accompanied by changes in bowel habits (including diarrhea, constipation); those with no pain in the right lower quadrant after appendicitis; patients with frequent oral ulcers without cause; unexplained skin, Patients with joint disease; first-degree relatives with IBD; healthy physical examination found in patients with single or multiple aphthous ulcers at the end of the ileum or different parts of the colon. 

排除标准:

①确诊为进展期CD/溃疡性结肠炎(UC)或筛查中发现可确诊的CD/UC患者;②确定患有其他免疫性疾病患者,如白塞氏病等;③结合病理考虑为淋巴瘤、疑似肿瘤等疾病者④存在常见肠道感染者(急慢性感染,含已确诊的肠道结核)⑤结肠镜检查前3个月内口服非甾体类等药物所致肠道损伤者⑥血管性病变者⑦乳糜泻患者⑧合并脏器衰竭的患者⑨不能接受排查或随访的患者。 

Exclusion criteria:

1. Diagnosed as advanced CD/ulcerative colitis (UC) or confirmed CD/UC patients are found in screening; 2. Identified patients with other immune diseases, such as Behcet's disease; 3. Combined with pathological considerations for lymph Tumors, suspected tumors and other diseases; 4. People with common intestinal infections (acute and chronic infection, including confirmed intestinal tuberculosis); 5. The intestinal damage caused by oral non-steroidal drugs within 3 months before colonoscopy ; 6. Patients with vascular disease ; 7. Patients with celiac disease; 8. Patients with complication of organ failure; 9. Patients who could not be examined or followed up. 

研究实施时间:

Study execute time:

From2019-05-01To 2020-12-31 

征募观察对象时间:

Recruiting time:

From2019-05-01To 2020-12-31 

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):

临床结局

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):

Clinical outcome

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):

综合亚临床期CD的血清学标志物、代谢组学、肠道微生物、病理学特点、影像学特点,结合临床和内镜特点,共同探讨CD的早期诊断方法

Index test:

Comprehensive serological markers, metabolomics, intestinal microbes, pathological features, imaging features of clinical subclinical CD, combined with clinical and endoscopic features, to explore early diagnosis of CD

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)

具备CD高危条件之一的患者,均接受结肠镜检查,一旦发现回肠末端或结肠不同部位的单发或多发表浅小溃疡、糜烂患者,则确定入组排查和随访。 CD高危条件包括:不明原因的顽固性慢性腹痛并伴有排便习惯改变的患者(包括腹泻、便秘);阑尾炎术后右下腹疼痛不缓解者;无原因的频繁口腔溃疡患者;不明原因的皮肤、关节病变患者;一级血缘亲属患有IBD者;健康体检发现回肠末端或结肠不同部位存在单发或多发阿弗它溃疡的患者。

例数:

Sample size:

310

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):

Patients with one of the high-risk conditions of CD were examined by colonoscopy. Once a single or multiple patients with shallow ulcers or erosions were found at the end of the ileum or in different parts of the colon, enrollment and follow-up were determined. High-risk conditions of CD including: 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):

①确诊为进展期CD/溃疡性结肠炎(UC)或筛查中发现可确诊的CD/UC患者;②确定患有其他免疫性疾病患者,如白塞氏病等;③结合病理考虑为淋巴瘤、疑似肿瘤等疾病者④存在常见肠道感染者(急慢性感染,含已确诊的肠道结核)⑤结肠镜检查前3个月内口服非甾体类等药物所致肠道损伤者⑥血管性病变者⑦乳糜泻患者⑧合并脏器衰竭的患者⑨不能接受排查或随访的患者。

例数:

Sample size:

160

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

1. Diagnosed as advanced CD/ulcerative colitis (UC) or confirmed CD/UC patients are found in screening; 2. Identified patients with other immune diseases, such as Behcet's disease; 3. Combined with pathological considerations for lymph Tumors, suspected tumors and other diseases; 4. People with common intestinal infections

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

陆军总医院 

单位级别:

三级甲等医院 

Institution
hospital:

Army General Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国中医科学院望京医院 

单位级别:

三级甲等医院 

Institution
hospital:

Wangjing Hospital, Chinese Academy of Traditional Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京大学第一医院 

单位级别:

三级甲等医院 

Institution
hospital:

The First Hospital of Peking University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京大学人民医院 

单位级别:

三级甲等医院 

Institution
hospital:

Peking University People's Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

血清标志物

指标类型:

主要指标 

Outcome:

serum marker

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肠道菌群标志物

指标类型:

主要指标 

Outcome:

Biomarkers of intestinal flora

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

代谢标志物

指标类型:

主要指标 

Outcome:

Metabolic marker

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

病理学特点

指标类型:

主要指标 

Outcome:

Pathological feature

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

影像学特点

指标类型:

次要指标 

Outcome:

Imaging features

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:

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后保存 

说明

3年

Fate of sample:

Preservation after use 

Note:

3 years

标本中文名:

粪便

组织:

Sample Name:

faeces

Tissue:

人体标本去向

使用后保存 

说明

3年

Fate of sample:

Preservation after use 

Note:

3 years

标本中文名:

肠道活检组织

组织:

Sample Name:

Intestinal biopsy tissue

Tissue:

人体标本去向

使用后保存 

说明

3年

Fate of sample:

Preservation after use 

Note:

3 years

标本中文名:

肠清液

组织:

Sample Name:

Bowel clear liquid

Tissue:

人体标本去向

使用后保存 

说明

3年

Fate of sample:

Preservation after use 

Note:

3 years

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 years
最大 Max age 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):

通过我们已建立的针对CD高危人群的筛查流程,在四家中心分别筛查、随访,建立亚临床期/早期CD患者队列。收集亚临床期/早期CD患者、进展期CD患者、正常人群、非特异性肠炎患者的基本资料、临床资料、影像学资料,和血、便、肠道活检标本。

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 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):

2020年3月 中国临床试验注册中心 (http://www.chictr.org.cn)

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

March 2020 ,China clinical trial registration center(http://www.chictr.org.cn)

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:

CRF+EDC(https://www.boshicloud.com/)

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

CRF+EDC(https://www.boshicloud.com/)

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-04-23
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