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血循环肿瘤细胞对乳腺癌复发、转移早期诊断和预后监测的前瞻性研究
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注册号:

Registration number:

ChiCTR-OCH-10000859 

最近更新日期:

Date of Last Refreshed on:

2015-06-13 

注册时间:

Date of Registration:

2010-04-24 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

血循环肿瘤细胞对乳腺癌复发、转移早期诊断和预后监测的前瞻性研究 

Public title:

A prospective study for early diagnosis of recurrence, metastasis and prognosis monitoring by circulating breast-tumor cells detecting 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

血循环肿瘤细胞对乳腺癌复发、转移早期诊断和预后监测的前瞻性研究 

Scientific title:

A prospective study for early diagnosis of recurrence, metastasis and prognosis monitoring by circulating breast-tumor cells detecting 

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:

任林 

研究负责人:

姜军 

Applicant:

Lin Ren 

Study leader:

Jun Jiang 

申请注册联系人电话:

Applicant telephone:

+86 023 68765633 

研究负责人电话:

Study leader's telephone:

+86 023 68765633 

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:

61465508@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

jcbd@medmail.com.cn 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://web.swhospital.com/rxzx/ 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

http://web.swhospital.com/rxzx/ 

申请注册联系人通讯地址:

第三军医大学西南医院乳腺疾病中心 

研究负责人通讯地址:

第三军医大学西南医院乳腺疾病中心 

Applicant address:

No.29, Gaotanyan Street, Shapingba District, Chongqing, China 

Study leader's address:

No.29, Gaotanyan 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:

KY201003 

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:

2010-03-18 

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:

No.29, Gaotanyan Street, Shapingba District, Chongqing, 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):

重庆

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

第三军医大学西南医院

具体地址:

重庆市沙坪坝区高滩岩正街29号

Institution
hospital:

Southwest Hospital, Third Military Medical University

Address:

No.29, Gaotanyan Street, Shapingba District, Chongqing, China

经费或物资来源:

第三军医大学西南医院 

Source(s) of funding:

Southwest Hospital, Third Military Medical University 

研究疾病:

乳腺癌 

Target disease:

Breast cancer 

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:

通过监测乳腺癌患者CTC的变化,判断乳腺癌预后;评价新辅助化疗疗效;为临床早期诊断复发/转移探索新方法。 

Objectives of Study:

To monitor the prognosis; to evaluate the effectiveness of neoadjuvant chemotherapy and early diagnosis according to detecting circulating breast-tumor cells 

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.签署知情同意书,并注明日期; 2.年龄18-70岁; 3.有能力依从方案; 4.无其余恶性肿瘤病史; 5.被诊断为乳腺癌的临床Ⅰ~Ⅳ期患者; 6.ECOG评分必须为0或1; 7.足够的血液功能:1)绝对中性粒细胞计数(ANC≧1.5×109/L)并且 2)血小板计数≧100×109/L并且 3)血红蛋白≧9g/dL(可以通过输血维持或超过此水平); 8.足够的肝功能: 总胆红素< 1.5 ULN,并且ALT,AST< 2.5 ULN ; 9.足够的肾功能:血肌酐≤1.25 ULN或者计算的肌酐清除率≥ 50 mL/min,并且尿蛋白 <2+; 10.凝血功能:入组前7天内国际标准化比值(INR) ≤1.5 并且部分凝血酶原时间(PPT或aPTT) ≤1.5 ULN。 

Inclusion criteria

1. The patients agree to participate in the trials and sign the informed consent and date; 2. Aged 18-70 years; 3. Be able to follow the scheme; 4. No other malignancy; 5. Patients were diagnosed with breast cancer; 6. ECOG score must be 0 or 1; 7. Enough blood functions: 1) absolute neutrophil count (ANC >=1.5*10^9/L) and 2) platelet count >=100*10^9/L and 3) hemoglobin >=9g/dL (May through blood transfusions to maintain or exceed This levels); 8. Adequate liver function: total bilirubin <1.5 ULN, and ALT, AST <2.5 ULN; 9. Adequate renal function: serum creatinine <=1.25 ULN or calculated creatinine clearance >=50 mL/min, and urine protein <2 +; 10. Clotting function: the first 7 days into the group of international normalized ratio (INR) <=1.5, and partial thromboplastin time (PPT or aPTT) <=1.5 ULN. 

排除标准:

1. 怀孕期或哺乳期的女性患者; 2. 患者已行肿块切除者; 3. 同时在进行其余试验研究; 4. 有明确手术禁忌症患者; 5. 研究人员认为其他原因不适合临床试验者。 

Exclusion criteria:

1. Pregnant or lactating female patients; 2. Tumor resection finished; 3. Still in other study at the same time; 4. Patients with clear surgical contraindications; 5. 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:

From2010-04-01To 2011-03-31 

干预措施:

Interventions:

组别:

总数

样本量:

348

Group:

Total

Sample size:

干预措施:

所有病例按照NCCN指南进行治疗,在治疗期各时间点抽取7.5ml外周静脉血进行血循环肿瘤细胞检查

干预措施代码:

Intervention:

All patients were treated according to NCCN guidelines, 7.5ml peripheral venous blood to take suction

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(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:

三甲 

Institution
hospital:

Southwest Hospital, Third Military Medical University  

Level of the institution:

Tertiary A Hopital 

测量指标:

Outcomes:

指标中文名:

诊断准确性

指标类型:

主要指标 

Outcome:

Diagnostic accuracy

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

特异度

指标类型:

主要指标 

Outcome:

Specificity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

敏感度

指标类型:

主要指标 

Outcome:

Sensitivity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

无疾病进展生存率

指标类型:

次要指标 

Outcome:

Progression-free survival

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

缓解率

指标类型:

次要指标 

Outcome:

Response rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总生存率

指标类型:

次要指标 

Outcome:

Overall Survival

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:

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):

NA

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

NA

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):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

第三军医大学西南医院

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

Southwest Hospital, Third Military Medical University

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:

第三军医大学统计学教研室

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

Department of Statistics, Third Military Medical University

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2010-04-24
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