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侵袭性NK细胞白血病的临床及多组学研究
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注册号:

Registration number:

ChiCTR1900024444 

最近更新日期:

Date of Last Refreshed on:

2019-07-12 

注册时间:

Date of Registration:

2019-07-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

侵袭性NK细胞白血病的临床及多组学研究 

Public title:

Clinical and multi-omics study on aggressive NK cell leukemia  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

侵袭性NK细胞白血病的临床及多组学研究 

Scientific title:

Clinical and multi-omics study on aggressive NK cell leukemia 

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:

杨小飞 

研究负责人:

陈苏宁 

Applicant:

Xiaofei Yang 

Study leader:

Suning Chen 

申请注册联系人电话:

Applicant telephone:

+86 18962156841 

研究负责人电话:

Study leader's telephone:

+86 13814881746 

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:

yangxiaofei1977@163.com 

研究负责人电子邮件:

Study leader's E-mail:

chensuning@sina.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:

江苏省苏州市十梓街188号 

研究负责人通讯地址:

江苏省苏州市十梓街188号 

Applicant address:

188 Shizi Street, Suzhou, Jiangsu, China  

Study leader's address:

suzhou shizi street 188 

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:

苏州大学附属第一医院 

Applicant's institution:

The First Affiliated Hospital of Soochow 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)伦审批第072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:

苏州大学附属第一医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of the First Affiliated Hospital of Soochow University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-05-22 

伦理委员会联系人:

陈亮 

Contact Name of the ethic committee:

Liang Chen 

伦理委员会联系地址:

苏州市十梓街188号 

Contact Address of the ethic committee:

188 Shizi Street, Suzhou, Jiangsu, 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:

苏州大学附属第一医院 

Primary sponsor:

The First Affiliated Hospital of Soochow University 

研究实施负责(组长)单位地址:

苏州市十梓街188号 

Primary sponsor's address:

188 Shizi Street, Suzhou, Jiangsu, 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):

江苏省

市(区县):

苏州市

Country:

China

Province:

Jiangsu

City:

Suzhou

单位(医院):

苏州大学附属第一医院

具体地址:

十梓街188号

Institution
hospital:

The First Affiliated Hospital of Soochow University

Address:

188 Shizi Street

经费或物资来源:

江苏省重点学科与人才战略经费 

Source(s) of funding:

key disciplines and talent strategy of jiangsu province 

研究疾病:

侵袭性NK细胞白血病 

Target disease:

aggressive NK cell leukemia 

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:

探索性研究/预试验 

Study phase:

研究目的:

观察侵袭性NK细胞白血病综合治疗的临床疗效,患者发病时炎症因子谱和基因组学的改变与临床疗效和预后的关系。 

Objectives of Study:

To observe clinical efficacy of comprehensive treatment for aggressive NK cell leukemia and to study correlation between inflammatory factor spectum and genomics change at disease onset and clinical effect and prognosis. 

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)符合侵袭性NK细胞白血病诊断标准,初治或复发患者均可; (2)年龄14-70岁; (3)ECOG 评分0-3级; (4)签署知情同意书患者必须有能力理解并愿意参加本研究,同时签署知情同意书。 

Inclusion criteria

(1) patients diagnosed with aggressive NK cell leukemia; (2) aged 14-70 years; (3) ECOG score 0-3; (4) patients with the capacity to understand this study and voluntary informed consent is given. 

排除标准:

(1)伴有其他进展的恶性肿瘤; (2)严重基础疾病患者不能耐受化疗者; (3)心功能不全患者:射血分数(EF)<30%,NYHA标准,心功能不全Ⅲ级以上; (4)拒绝入组该研究患者。 

Exclusion criteria:

(1) accompanied with other advanced cancer; (2) patients with severe underlying disease which can't tolerate chemotherapy; (3) cardiac dysfunction:ejection fraction(EF)<30%, cardiac dysfunction above grade III; (4) refuse to attend this study. 

研究实施时间:

Study execute time:

From2019-07-31To 2021-07-31 

干预措施:

Interventions:

组别:

单臂

样本量:

15

Group:

single arm

Sample size:

干预措施:

化疗+芦可替尼

干预措施代码:

Intervention:

chemotherapy+Ruxolitinib

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏省 

市(区县):

苏州 

Country:

China 

Province:

Jiangsu 

City:

Suzhou 

单位(医院):

苏州大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Soochow University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

生存时间

指标类型:

主要指标 

Outcome:

survival time

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:

组织:

Sample Name:

none

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

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 14 years
最大 Max age 70 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):

试验结束6个月内原始数据上传到临床试验公共管理平台ResMan (www.medresman.org)

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

raw data submitted to the public management platform of clinical trial (ResMan (www.medresman.org)) within 6 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:

CRF+ResMan

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

CRF+ResMan

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-07-12
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