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建立克罗恩病病人对英夫利西单抗原发性无应答的预测模型
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注册号:

Registration number:

ChiCTR1900026091 

最近更新日期:

Date of Last Refreshed on:

2019-09-20 

注册时间:

Date of Registration:

2019-09-20 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

建立克罗恩病病人对英夫利西单抗原发性无应答的预测模型 

Public title:

Development of a predictive nomogram for primary non-response to infliximab in patients with Crhon's disease 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

建立克罗恩病病人对英夫利西单抗原发性无应答的预测模型:一项多中心研究 

Scientific title:

Development of a predictive nomogram for primary non-response to infliximab in patients with Crhon's disease: a multicenter study 

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:

叶晓琪 

研究负责人:

张盛洪 

Applicant:

Xiaoqi Ye 

Study leader:

Shenghong Zhang 

申请注册联系人电话:

Applicant telephone:

+86 13826479129 

研究负责人电话:

Study leader's telephone:

+86 13570527027 

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:

yexq3@mail2.sysu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

shenghongzhang@163.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:

广东省广州市越秀区中山二路58号 

研究负责人通讯地址:

广东省广州市越秀区中山二路58号 

Applicant address:

58 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, China 

Study leader's address:

58 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, China 

申请注册联系人邮政编码:

Applicant postcode:

510000 

研究负责人邮政编码:

Study leader's postcode:

510000 

申请人所在单位:

中山大学附属第一医院 

Applicant's institution:

The First Affiliated Hospital of Sun Yat-sen 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:

[2019]349号 

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:

中山大学附属第一医院临床科研和实验动物伦理委员会 

Name of the ethic committee:

ICE for Clinical Research and Animal Trials of the First Affiliated Hospital of Sun Yat-sen University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-09-12 

伦理委员会联系人:

林海锋 

Contact Name of the ethic committee:

Haifeng Lin 

伦理委员会联系地址:

广东省广州市越秀区中山二路58号,中山大学附属第一医院临床科研和实验动物伦理委员会 

Contact Address of the ethic committee:

ICE for Clinical Research and Animal Trials of the First Affiliated Hospital of Sun Yat-sen University, 58 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, 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:

中山大学附属第一医院 

Primary sponsor:

The First Affiliated Hospital of Sun Yat-sen University 

研究实施负责(组长)单位地址:

广东省广州市越秀区中山二路58号 

Primary sponsor's address:

58 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

无经费来源 

Source(s) of funding:

No funding 

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:

观察性研究 

Study type:

Observational study 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

通过建立克罗恩病病人对英夫利西单抗原发性无应答的预测模型,筛选出对英夫利西单抗应答的病人,以指导临床选药。 

Objectives of Study:

By constructing a predictive nomogram for primary non-response to infliximab in patients with Crohn's disease, we can select patients who is responsive to infliximab and treat them properly. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

1.在中心诊断为克罗恩病:根据临床表现、影像学、内镜、组织学证据。 2.英夫利西单抗治疗前内镜下处于疾病活动期(CDEIS>3分) 3.在中心完成英夫利西单抗诱导治疗(第0,2,6周按5mg/kg静滴) 

Inclusion criteria

1. A diagnosis of Crohn's disease based on clinical, radiographic, endoscopic, and histological evidence in the center; 2. Endoscopic active with Crohns disease index of severity (CDEIS) more than 3 before treatment of infliximab; 3. Complement of induction of infliximab of 5mg/kg at week 0, 2, 6 in the medical center. 

排除标准:

1.有回结肠切除手术史 2.缺第0周或第14周肠镜 3.资料不完整 

Exclusion criteria:

1. Previous ileac, colonic or ileocolonic resection; 2. Lack of ileocolonoscopy before induction of IFX or at week 14 since the first induction of IFX; 3. Incomplete data. 

研究实施时间:

Study execute time:

From2019-09-19To 2019-10-31 

干预措施:

Interventions:

组别:

Case series

样本量:

343

Group:

Case series

Sample size:

干预措施:

英夫利西单抗

干预措施代码:

Intervention:

infliximab

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

中山大学附属第一医院 

单位级别:

三甲医院 

Institution
hospital:

The First Affiliated Hospital of Sun Yat-sen University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江大学医学院邵逸夫医院 

单位级别:

三甲医院 

Institution
hospital:

Sir Run Run Shaw Hospital Zhejiang University, School of Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江大学医学院附属第二医院 

单位级别:

三甲医院 

Institution
hospital:

The Second Affiliated Hospital of Zhejiang University School of Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津医科大学总医院 

单位级别:

三甲医院 

Institution
hospital:

Tianjin Medical University General Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

对英夫利西单抗是否原发性无应答

指标类型:

主要指标 

Outcome:

Primary non-response to infliximab

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:

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 9 years
最大 Max age 58 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):

观察性研究,无需随机。

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4月公开在中山大学附属第一医院IBD研究中心

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

IBD center of the First Affiliated Hospital of SYSU in April 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:

数据录入在excel中

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

data are recorded in excel

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-09-20
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