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USP25调控STAT3依赖性IL-10/IL-22抗炎信号在溃疡性结肠炎中作用及机制研究
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注册号:

Registration number:

ChiCTR1900021015 

最近更新日期:

Date of Last Refreshed on:

2019-01-25 

注册时间:

Date of Registration:

2019-01-25 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

USP25调控STAT3依赖性IL-10/IL-22抗炎信号在溃疡性结肠炎中作用及机制研究 

Public title:

Role of USP25 regulating STAT3-dependent anti-inflammatory pathway of IL-10 / IL-22 in ulcerative colitis and its mechanism 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

USP25调控STAT3依赖性IL-10/IL-22抗炎信号在溃疡性结肠炎中作用及机制研究 

Scientific title:

Role of USP25 regulating STAT3-dependent anti-inflammatory pathway of IL-10 / IL-22 in ulcerative colitis and its mechanism 

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:

张吉翔 

研究负责人:

董卫国 

Applicant:

Jixiang Zhang 

Study leader:

Weiguo Dong 

申请注册联系人电话:

Applicant telephone:

+86 13659857350 

研究负责人电话:

Study leader's telephone:

+86 13986167388 

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:

zhangjixiang@whu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

dwg@whu.edu.cn 

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:

湖北省武汉市武昌区张之洞路99号 

研究负责人通讯地址:

湖北省武汉市武昌区张之洞路99号 

Applicant address:

99 Zhangzhidong Road, Wuchang District, Wuhan, Hubei, China 

Study leader's address:

99 Zhangzhidong Road, Wuchang District, Wuhan, Hubei, China 

申请注册联系人邮政编码:

Applicant postcode:

430060 

研究负责人邮政编码:

Study leader's postcode:

430060 

申请人所在单位:

武汉大学人民医院 

Applicant's institution:

Renmin Hospital of Wuhan 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:

WDRY2018-K033 

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:

武汉大学人民医院临床研究伦理委员会 

Name of the ethic committee:

Clinical Ethics Committee of Renmin Hospital of Wuhan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-11-27 

伦理委员会联系人:

陈红 

Contact Name of the ethic committee:

Hong Chen 

伦理委员会联系地址:

湖北省武汉市武昌区张之洞路99号 

Contact Address of the ethic committee:

99 Zhangzhidong Road, Wuchang District, Wuhan, Hubei, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

027-88041911-81353 

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:

武汉大学人民医院 

Primary sponsor:

Renmin Hospital of Wuhan University 

研究实施负责(组长)单位地址:

湖北省武汉市武昌区张之洞路99号 

Primary sponsor's address:

99 Zhangzhidong Road, Wuchang District, Wuhan, Hubei, 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):

湖北

市(区县):

武汉

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

武汉大学人民医院

具体地址:

武昌区张之洞路99号

Institution
hospital:

Renmin Hospital of Wuhan University

Address:

99 Zhangzhidong Road, Wuchang District

经费或物资来源:

国家自然科学基金(No.81870392) 

Source(s) of funding:

National Natural Science Foundation of China (No.81870392) 

研究疾病:

溃疡性结肠炎 

Target disease:

ulcerative colitis 

研究疾病代码:

 

Target disease code:

 

研究类型:

病因学/相关因素研究 

Study type:

Cause/Relative factors study 

研究所处阶段:

基础科学研究 

Study phase:

Basic Science 

研究目的:

明确USP25在溃疡性结肠炎中的作用及相关分子机制,为溃疡性结肠炎的临床治疗提供新靶点。 

Objectives of Study:

We aim to clarify the effect and mechanism of USP25 in the occurrence and development of ulcerative colitis as well as offer potential therapeutic methods for ulcerative colitis. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

1. 性别不限,年龄18至80岁; 2. 明确诊断的UC患者(诊断标准参考第15版《实用内科学》);于我院就诊的非UC患者; 3. 同意参与临床试验并签署知情同意书。 

Inclusion criteria

1. Aged 18 to 80 years; 2. Positive diagnosis of ulcerative colitis and patients without ulcerative colitis; 3. Patients who agree for participating in the clinical trail and sign informed consent.  

排除标准:

1. 严重的心肺疾病者(NYHA心功能IV级或呼吸功能衰竭); 2. 明显肝功能损害者(谷丙转氨酶(ALT)≥ 5 ULN(参考值上限),碱性磷酸酶(ALP)≥ 2 ULN,或 ALT ≥ 3 ULN 且总胆红素(TBil)≥ 2 ULN ); 3. 明显肾功能损害(血清肌酐≥2 mg/dL或肾小球滤过率 GFR<40 mL/min); 4. 确诊或怀疑合并恶性肿瘤(含肠道肿瘤)者; 5. 严重凝血功能障碍者; 6. 重度全身性感染者; 7. 妊娠哺乳期妇女或不排除妊娠可能的妇女; 8. 研究者认为不适合参加者。 

Exclusion criteria:

1. Severe respiratory and cardiovascular diseases; 2. Severe liver damage; 3. Severe renal impairment; 4. Malignancy; 5. Bleeding disorders; 6. Severe systemic infection; 7. pregnancy or prepare to be pregnancy or lactation; 8. Not suitable for the clinical trail. 

研究实施时间:

Study execute time:

From2019-01-01To 2022-12-31 

干预措施:

Interventions:

组别:

Chort 1 溃疡性结肠炎患者

样本量:

150

Group:

Chort 1 Patents with ulcerative colitis

Sample size:

干预措施:

N/A

干预措施代码:

Intervention:

N/A

Intervention code:

组别:

Chort 2 健康人群

样本量:

150

Group:

Chort 2 Healthy people

Sample size:

干预措施:

N/A

干预措施代码:

Intervention:

N/A

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

武汉大学人民医院 

单位级别:

三甲医院 

Institution
hospital:

Renmin Hospital of Wuhan University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

USP25 基因

指标类型:

主要指标 

Outcome:

USP25 DNA

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

USP25 蛋白

指标类型:

主要指标 

Outcome:

USP25 protein

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白介素-10

指标类型:

主要指标 

Outcome:

IL-10

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白介素-22

指标类型:

主要指标 

Outcome:

IL-22

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白细胞介素-6

指标类型:

次要指标 

Outcome:

IL-6

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肿瘤坏死因子-α

指标类型:

次要指标 

Outcome:

TNF-α

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

干扰素-γ

指标类型:

次要指标 

Outcome:

IFN-γ

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:

结直肠组织

Sample Name:

blood

Tissue:

tissues from colorectum

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 18 years
最大 Max age 80 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):

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):

试验完成后6个月内公开

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

within six months after the trial complete

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:

纸质病例记录表和excel、word共同保存

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

Case Record Form, excel, word

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-01-25
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