今天是:2019-11-23 星期六

刘晓曼医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 胃肠道间质瘤患者伊马替尼的药物基因组学研究
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注册号:

Registration number:

ChiCTR1900026010 

最近更新日期:

Date of Last Refreshed on:

2019-09-17 

注册时间:

Date of Registration:

2019-09-17 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

刘晓曼医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 胃肠道间质瘤患者伊马替尼的药物基因组学研究 

Public title:

Investigation of Imatinib Pharmacogenomics in Patients With Gastrointestinal Stromal Tumor 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基因多态性对胃肠道间质瘤患者伊马替尼血药浓度和响应影响的研究 

Scientific title:

Investigation of the Possible Role of Genetic Polymorphism on Both Plasma Level and Response of Imatinib in Patients With Gastrointestinal Stromal Tumor 

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:

刘晓曼 

研究负责人:

刘晓曼 

Applicant:

Xiaoman Liu 

Study leader:

Xiaoman Liu 

申请注册联系人电话:

Applicant telephone:

+86 15815859526 

研究负责人电话:

Study leader's telephone:

+86 15815859526 

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:

56873620@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

56873620@qq.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:

广州市中山二路58号 

研究负责人通讯地址:

广州市中山二路58号 

Applicant address:

58 Second Zhongshan Road, Guangzhou, China 

Study leader's address:

58 Second Zhongshan Road, Guangzhou, 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:

中山大学附属第一医院 

Applicant's institution:

The First Affiliated Hospital, Sun Yat-Sen University 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

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:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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, Sun Yat-Sen University 

研究实施负责(组长)单位地址:

广州市中山二路58号 

Primary sponsor's address:

58 Second Zhongshan Road, Guangzhou, 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):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

中山大学附属第一医院

具体地址:

中山二路58号

Institution
hospital:

The First Affiliated Hospital, Sun Yat-Sen University

Address:

58 Second Zhongshan Road

经费或物资来源:

中国国家自然科学基金委 

Source(s) of funding:

National Natural Science Foundation of China 

研究疾病:

胃肠道间质瘤 

Target disease:

Gastrointestinal stromal tumor 

研究疾病代码:

 

Target disease code:

 

研究类型:

基础科学研究 

Study type:

Basic Science 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

伊马替尼是治疗胃肠道间质瘤患者的一线用药。尽管其疗效好,但伊马替尼的血药浓度和不良反应的发生有较大的个体差异,可能会导致治疗失败。基因多态性可能会影响伊马替尼血药浓度和响应。 本项目拟通过基因型检测,探索基因型与胃肠道间质瘤患者伊马替尼的血药浓度和响应的关系。 本研究旨在为胃肠道间质瘤患者提供个体化治疗的新策略,从而提高药物疗效和减少不良反应的发生。 

Objectives of Study:

Imatinib is used for treatment of gastrointestinal stromal tumor (GIST). Despite its efficacy, there is a large inter-individual variability in imatinib plasma concentrations and adverse events, which may lead to treatment failure, adverse events and disease progression. Genetic polymorphisms may affect imatinib plasma level and response. The study aims to investigate the possible effect of genetic polymorphisms by genotyping on the plasma level and response of imatinib in patients with GIST. The study also aims to provide GIST patients with a personalised treatment option, thereby probably improving the response and reducing the side effects. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

1. 年龄在18-75岁间; 2. 诊断为胃肠道间质瘤; 3. 已服用伊马替尼至少6个月; 4. 身体状态基本良好,无重大器官疾病; 5. Eastern Cooperative Oncology Group (ECOG)状态评分≤3。 

Inclusion criteria

1. Aged 18 to 75 years; 2. Documented diagnosis of GIST; 3. Imatinib treatment for at least 6 months; 4. Generally in good condition with no major organ disease; 5. Eastern Cooperative Oncology Group (ECOG) Performance Status Grade <= 3. 

排除标准:

1. 依从性不高的患者; 2. 病历资料不齐全的患者。 

Exclusion criteria:

1. Poor compliance to treatment; 2. Insufficient clinical data. 

研究实施时间:

Study execute time:

From2019-11-01To 2024-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

600

Group:

Case series

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):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

中山大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital, Sun Yat-Sen University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

基因型

指标类型:

主要指标 

Outcome:

Genotype

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

伊马替尼血药浓度

指标类型:

主要指标 

Outcome:

Imatinib plasma level

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

无进展生存期

指标类型:

主要指标 

Outcome:

Progression-free survival

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总生存期

指标类型:

主要指标 

Outcome:

Overall survival

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

完全缓解率

指标类型:

次要指标 

Outcome:

Complete response

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

部分缓解率

指标类型:

次要指标 

Outcome:

Partial response

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

水肿

指标类型:

次要指标 

Outcome:

Oedema

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

皮疹

指标类型:

次要指标 

Outcome:

Rash

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

贫血

指标类型:

次要指标 

Outcome:

Anemia

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

结膜出血

指标类型:

次要指标 

Outcome:

Conjunctival hemorrhage

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

病情稳定率

指标类型:

次要指标 

Outcome:

Stable disease

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:

Sample Name:

Blood

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 75 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):

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):

公开发表论文

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

Publication

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:

原始数据及病例报告表保存于中山大学附属第一医院

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

The original data and CRFs will be kept by the First Affiliated Hospital, Sun Yat-sen University

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2019-09-17
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