今天是:2019-11-23 星期六

浙江省造血干细胞移植患者CRE连续性筛查的临床研究
下载XML文档

注册号:

Registration number:

ChiCTR1900025785 

最近更新日期:

Date of Last Refreshed on:

2019-09-08 

注册时间:

Date of Registration:

2019-09-08 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

浙江省造血干细胞移植患者CRE连续性筛查的临床研究 

Public title:

A clinical study for CRE continous screening in patients with hematopoietic stem cell transplantation 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

浙江省造血干细胞移植患者CRE连续性筛查的临床研究 

Scientific title:

A clinical study for CRE continous screening in patients with hematopoietic stem cell transplantation 

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:

杨婷婷 

研究负责人:

施继敏 

Applicant:

Tingting Yang 

Study leader:

Jimin Shi 

申请注册联系人电话:

Applicant telephone:

+86 15157313942 

研究负责人电话:

Study leader's telephone:

+86 13857119077 

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:

15157313942@139.com 

研究负责人电子邮件:

Study leader's E-mail:

Jiminshi@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:

浙江省杭州市庆春路79号 

研究负责人通讯地址:

浙江省杭州市庆春路79号 

Applicant address:

79 Qingchun Road, Hangzhou, Zhejiang, China 

Study leader's address:

79 Qingchun Road, Hangzhou, Zhejiang, 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:

浙江大学医学院附属第一医院 

Applicant's institution:

The First Affiliated Hospital of Zhejiang University School of Medicine 

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)科研快审第(1351)号 

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:

浙江大学医学院附属第一医院 科研伦理审查委员会  

Name of the ethic committee:

The Ethics Committee of the First Affiliated Hosptial, School of Medicine, Zhejiang 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:

殷琳 

Contact Name of the ethic committee:

Lin Yin 

伦理委员会联系地址:

浙江省杭州市上城区庆春路79号 

Contact Address of the ethic committee:

79 Qingchun Road, Shangcheng District, Hangzhou, Zhejiang, 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:

浙江大学医学院附属第一医院 

Primary sponsor:

The First Affiliated Hospital of Zhejiang University School of Medicine  

研究实施负责(组长)单位地址:

浙江省杭州市庆春路79号 

Primary sponsor's address:

79 Qingchun Road, Hangzhou, Zhejiang, 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):

浙江

市(区县):

杭州

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江大学医学院附属第一医院

具体地址:

庆春路79号

Institution
hospital:

The First Affiliated Hospital of Zhejiang University School of Medicine

Address:

79 Qingchun Road

经费或物资来源:

自筹 

Source(s) of funding:

self-funding 

研究疾病:

碳青霉烯类耐药肠杆菌科细菌感染 

Target disease:

Carbapenem-resistant Enterobacteriaceae bacterial infection  

研究疾病代码:

 

Target disease code:

 

研究类型:

筛查 

Study type:

Screening 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

主要研究目的: 1.造血干细胞移植患者中CRE筛查的阳性率; 2.CRE筛查的阳性和阴性患者出现CRE感染的发生率; 3.CRE筛查的阳性和阴性患者造血重建、移植并发症、生存的差异比较。 

Objectives of Study:

the main research objectives: 1. The positive rate of CRE screening in patients with hematopoietic stem cell transplantation; 2. The incidence of CRE infection in positive and negative patients with CRE screening; 3. Comparison of hematopoietic reconstitution, transplantation complications and survival between positive and negative patients with CRE screening. 

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:

1.受试者或其法定代理人在临床研究开始前签署知情同意书; 2.确诊为血液系统恶性肿瘤并接受造血干细胞移植。 

Inclusion criteria

1. The informed consent is signed by the subjects or their legal representatives before the start of clinical research; 2. Diagnosis of hematological malignancies and acceptance of hematopoietic stem cell transplantation. 

排除标准:

无法进行肛门拭子筛查; 

Exclusion criteria:

1. CRE infection is confirmed before hematopoietic stem cell transplantation; 2. failure to perform anal test. 

研究实施时间:

Study execute time:

From2019-08-23To 2020-12-31 

干预措施:

Interventions:

组别:

CRE定植组

样本量:

600

Group:

Case series

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江大学医学院附属第一医院 

单位级别:

三级甲等医院 

Institution
hospital:

the First Affiliated Hospital of 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):

杭州 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江大学附属第二医院 

单位级别:

三级甲等医院 

Institution
hospital:

the Second Affliated Hospital of Zhejiang University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江大学医学院附属邵逸夫医院 

单位级别:

三级甲等医院 

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):

杭州 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江省中医院 

单位级别:

三级甲等医院 

Institution
hospital:

Zhejiang Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江省人民医院 

单位级别:

三级甲等医院 

Institution
hospital:

Zhejiang Provincial People's Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江省立同德医院 

单位级别:

三级甲等医院 

Institution
hospital:

Tongde Hospital of Zhejiang Province  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江省肿瘤医院 

单位级别:

三级甲等医院 

Institution
hospital:

Zhejiang Province Cancer Hospital  

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):

温州医科大学附属第一医院 

单位级别:

三级甲等医院 

Institution
hospital:

The First Affiliated Hospital of Wenzhou Medical 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):

杭州市第一人民医院 

单位级别:

三级甲等医院 

Institution
hospital:

Hangzhou First People's Hospital  

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):

绍兴人民医院 

单位级别:

三级甲等医院 

Institution
hospital:

Shaoxing People's Hospital  

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):

丽水中心医院 

单位级别:

三级甲等医院 

Institution
hospital:

Lishui Central Hospital  

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):

金华中心医院 

单位级别:

三级甲等医院 

Institution
hospital:

Jinhua Municipal Central Hospital  

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):

金华市人民医院 

单位级别:

三级甲等医院 

Institution
hospital:

Jinhua People's Hospital  

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):

宁波人民医院 

单位级别:

三级乙等医院 

Institution
hospital:

Ningbo People's Hospital  

Level of the institution:

Tertiary B Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

宁波鄞州人民医院 

单位级别:

三级乙等医院 

Institution
hospital:

Ningbo Yinzhou People's Hospital  

Level of the institution:

Tertiary B Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江省台州医院 

单位级别:

三级甲等医院 

Institution
hospital:

Taizhou hospital of Zhejiang Province  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

CRE 检出率

指标类型:

主要指标 

Outcome:

the rate of CRE

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CRE 感染率

指标类型:

主要指标 

Outcome:

the rate of CRE infection

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CRE 死亡率

指标类型:

主要指标 

Outcome:

CRE mortality

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:

肛拭子

组织:

肛门

Sample Name:

Anal swab

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

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:

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 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):

未使用

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

Not used

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):

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:

Not stated

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

Not stated

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-09-08
返回列表