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纳米炭-表阿霉素混悬液对乳腺癌腋窝淋巴结靶向化疗的临床研究
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注册号:

Registration number:

ChiCTR-TRC-13003419 

最近更新日期:

Date of Last Refreshed on:

2016-02-23 

注册时间:

Date of Registration:

2013-08-05 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

纳米炭-表阿霉素混悬液对乳腺癌腋窝淋巴结靶向化疗的临床研究 

Public title:

A clinical randomized controlled study for the applications of carbon nanoparticles-epirubicin suspension in axillary lymph nodes targeted chemotherapy of breast cancer 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

纳米炭-表阿霉素混悬液对乳腺癌腋窝淋巴结靶向化疗的临床研究 

Scientific title:

A clinical randomized controlled study for the applications of carbon nanoparticles-epirubicin suspension in axillary lymph nodes targeted chemotherapy of breast cancer 

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:

张永松 

研究负责人:

范林军 

Applicant:

Yongsong Zhang 

Study leader:

Linjun FAN 

申请注册联系人电话:

Applicant telephone:

+86 023 68765636 

研究负责人电话:

Study leader's telephone:

+86 0 13389668035 

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:

13006423336@163.com 

研究负责人电子邮件:

Study leader's E-mail:

flj212@medmail.com.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:

重庆市沙坪坝区高滩岩正街29号西南医院乳腺中心 

研究负责人通讯地址:

重庆市沙坪坝区高滩岩正街29号西南医院乳腺中心 

Applicant address:

29 Gaotanyan Main Street, Shapingba District, Chongqing, China 

Study leader's address:

29 Gaotanyan Main Street, Shapingba District, Chongqing, China 

申请注册联系人邮政编码:

Applicant postcode:

400038 

研究负责人邮政编码:

Study leader's postcode:

400038 

申请人所在单位:

第三军医大学西南医院乳腺疾病中心 

Applicant's institution:

Breast Disease Center, Southwest Hospital, Third Military Medical University, Chongqing 

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:

KY2013(25) 

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:

第三军医大学西南医院医学伦理委员会 

Name of the ethic committee:

Ethics Committee of Southwest Hospital, Third Military Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-07-26 

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:

第三军医大学西南医院 

Primary sponsor:

Southwest Hospital, Third Military Medical University 

研究实施负责(组长)单位地址:

重庆市沙坪坝区高滩岩正街29号 

Primary sponsor's address:

29 Gaotanyan Main Street, Shapingba District, Chongqing, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

重庆市科技攻关计划重点项目基金 

Source(s) of funding:

The key project of Science and technology study foundation of Chongqing 

研究疾病:

乳腺癌 

Target disease:

Breast cancer 

研究疾病代码:

174.901 (ICD-9) 

Target disease code:

174.901 (ICD-9) 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

纳米炭吸附表阿霉素对乳腺癌腋窝淋巴结的靶向化疗作用 

Objectives of Study:

To investigate the effects of carbon nanoparticles -epirubicin targeted chemotherapy for axillary lymph nodes of breast cancer. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1.年龄18~70岁的女性患者;2.术前穿刺活检明确确诊为浸润性乳腺癌;3.术前检查有腋窝淋巴结肿大,无腋窝手术史;4.无远处转移;5.无胸壁乳房局部放疗史 ;6.非妊娠、哺乳期乳腺癌;7.心肺肝肾检查无明显异常,无明显凝血功能障碍等手术禁忌症;8.无其余恶性肿瘤病史;9.有能力依从方案,自愿参加研究并签署知情同意书。 

Inclusion criteria

1. Female aged 18-70 years; 2. The diagnosis of invasive breast cancer has been confirmed by preoperative core needle biopsy; 3. Has enlarged axillary lymph nodes on preoperative examination, no axillary operation history; 4. Without distant metastasis; 5. No chest wall and breast radiotherapy history; 6. Non pregnant and lactating breast cancer; 7. Heartlungliver and kidney shoud no obvious abnormalities, no coagulation dysfunction and other operation contraindication; 8. No other malignancy; 9. Be able to follow the scheme, the patients agree to participate in the trials and sign the informed consent and date. 

排除标准:

1.年龄18<岁,或>70岁;2.术前检查发现肿瘤远处转移;3.曾有腋窝手术史;4.妊娠期和哺乳期妇女;5.合并严重心、肝、肾、内分泌系统疾病的患者,且以上疾病预期生存期<2年者;6.因各种原因不能按时就诊,复查的患者;7.对纳米炭和表阿霉素过敏者;8.不愿意接受纳米炭-表阿霉素混悬液治疗者;9.研究人员认为其他原因不适合临床试验者。 

Exclusion criteria:

1. Tumor distant metastasis; 2. Had axillary operation history; 3. Pregnant or lactating female patients; 4. Complicated serious disease (such as: heart exclus diseaseliver diseasekidney disease,etc) for exsist less than 2 years by estimate; 5. Patients who are not convenient to go to the doctors' office for recheck for any reason; 6. Have a particular allergy to Carbon nanoparticles or epirubicin; 7. The researchers believe that the patients are not suitable for this clinical trial for other reasons. 

研究实施时间:

Study execute time:

From2013-08-01To 2015-08-01 

征募观察对象时间:

Recruiting time:

From2013-08-01To 2020-08-01 

干预措施:

Interventions:

组别:

靶向组

样本量:

100

Group:

targeted group

Sample size:

干预措施:

术前经乳晕周围皮下分4点注射纳米炭-表阿霉素混悬液3ml;乳腺癌改良根治术

干预措施代码:

Intervention:

3ml carbon nanoparticles-epirubici suspension was injected into 4 points around the areola before operation; Modified radical mastectomy of breast cancer

Intervention code:

组别:

示踪组

样本量:

100

Group:

tracer group

Sample size:

干预措施:

术前经乳晕周围皮下分4点注射纳米炭混悬注射液1ml ;乳腺癌改良根治术

干预措施代码:

Intervention:

1ml carbon nanoparticles suspension was injected into 4 points around the areola before operation; Modified radical mastectomy of breast cancer

Intervention code:

组别:

对照组

样本量:

100

Group:

Control group

Sample size:

干预措施:

乳腺癌改良根治术

干预措施代码:

Intervention:

Modified radical mastectomy of breast cancer

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆市 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

第三军医大学西南医院 

单位级别:

三级甲等 

Institution
hospital:

Southwest Hospital, Third Military Medical University  

Level of the institution:

Tertiary 

测量指标:

Outcomes:

指标中文名:

1、3、5年复发/转移率,生存率,总生存率

指标类型:

主要指标 

Outcome:

1, 3, 5 years relapse/ metastasize Rate; survival rate; overall survival rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

腋窝淋巴结内药物浓度测定

指标类型:

主要指标 

Outcome:

Determination of drug concentration in axillary lymph nodes

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:

腋窝淋巴结

组织:

腋窝淋巴结

Sample Name:

Axillary lymph nodes

Tissue:

Axillary lymph nodes

人体标本去向

使用后保存 

说明

30年

Fate of sample:

Preservation after use 

Note:

30 years

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 18 years
最大 Max age 70 years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

随机数字表法

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

The method of random digits table

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

否No

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):

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:

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

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2013-08-05
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