此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

microRNA of Human Epidermal Growth Factor Receptor 2 (HER2)Positive Patient Treated With Herceptin

2016年10月12日 更新者:Erwei Song, M.D., Ph.D.、Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

A Perspective Study of the Predictive Value of microRNA in Patients With HER2 Positive Advanced Stage Breast Cancer Who Were Treated With Herceptin

This projective observational study is planned to enroll more than 300 advanced breast cancer patients, who were proved as Her-2 positive using fluorescence in situ hybridization (FISH) and / or immunohistochemistry, and 100 healthy donors as control. Before treatment, the plasma microRNA will be collected and detected by microRNA extraction kit and quantitative polymerase chain reaction (qPCR), respectively. After analyzed their microRNA expression by microRNA predictive model, previously reported by our team, all of enrolled patients will be classified as "probable sensitive group" or "probable resistant group". Herceptin combined with other chemotherapy will be the backbone of salvage treatment and used for at least 3 months; the change of local masses and metastasis lesions after treatment will be documented to evaluate the response. Based on these results, investigator aim to construct a mathematical predictive model by analyzing the correlation of baseline microRNA expression level and the prognosis of patients. And a diagnosis microRNA kit will be planned and manufactured

研究概览

研究类型

观察性的

注册 (预期的)

300

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Guangdong
      • Guangzhou、Guangdong、中国、510120
        • 招聘中
        • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

取样方法

非概率样本

研究人群

advanced breast cancer patients first diagnosis in Sun Yat-sen Memorial Hospital, Sun Yat-sen University. Informed consent must be obtained for all of the included patients.

描述

Inclusion Criteria:

  1. The patients signed the written informed consent
  2. female patient who is ≥ 18yrs,
  3. HER2 positive: immunohistochemistry (+++) or FISH (+)
  4. stage IV
  5. the patients have no history of chemotherapy ,hormone therapy,radiotherapy or surgery after diagnosis of breast cancer
  6. the result of patients' blood tests are as follow: WBC≥3.0×109/L; Plt≥100×109/L;AST/SGOT or ALT/AGPT≤tripple of normal upper limit; Creatinine<double of the normal upper limit
  7. ECOG scores are 0 or 1 .
  8. The patient is able to take oral pills

Exclusion Criteria:

  1. The patient was never exposed to herceptin.
  2. The patient suffered from other non-breast malignancy in the last 5 years, except for cervical carcinoma in situ, radical basal cell carcinoma or squamous cell carcinoma.
  3. The life expectancy is less than 3 months.
  4. Severe hepatic function disorder, Child Pugh grade C.
  5. Severe cardiac function disorder, cardiac function is more than grade III;
  6. Prolonged QT interval;
  7. Arrhythmia or taking anti-arrhythmia drugs;
  8. Pregnant or breast feeding female.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Herceptin probable sensitive group
Plasma microRNAs will be collected using microRNA extraction kit according to manufacturer's instructions; and their expression levels are analyzed by quantitative polymerase chain reaction (qPCR).According to microRNAs - herceptin predictive model(reported by our team), the patients will be considered as Herceptin probable sensitive group
Capecitabine will be administered orally at a dose of 2500mg/m2 daily for 3 months (Day 1 to 14 of a 21-day cycle)
其他名称:
  • 希罗达
patients will receive herceptin intravenous infusion at a dose of 6mg on day 1 of each cycle
其他名称:
  • 赫赛汀
Herceptin probable resistant group
Plasma microRNAs will be collected using microRNA extraction kit according to manufacturer's instructions; and their expression levels are analyzed by quantitative polymerase chain reaction (qPCR).According to microRNAs - herceptin predictive model(reported by our team), the patients will be considered as Herceptin probable resistant group
Capecitabine will be administered orally at a dose of 2500mg/m2 daily for 3 months (Day 1 to 14 of a 21-day cycle)
其他名称:
  • 希罗达
patients will receive herceptin intravenous infusion at a dose of 6mg on day 1 of each cycle
其他名称:
  • 赫赛汀

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Progress-free survival of patients
大体时间:progression free survival (PFS) was defined as the interval from the diagnosis of advanced breast cancer with HER2 positive to disease progression, relapse, death due to any causes or last follow-up.The follow-up interval is 2 years.
progression free survival (PFS) was defined as the interval from the diagnosis of advanced breast cancer with HER2 positive to disease progression, relapse, death due to any causes or last follow-up.The follow-up interval is 2 years.
overall survival of patients
大体时间:Overall survival was defined as the interval from the diagnosis of advanced breast cancer with HER2 positive to death due to any causes or last follow-up,The follow-up interval is 2 years.
Overall survival was defined as the interval from the diagnosis of advanced breast cancer with HER2 positive to death due to any causes or last follow-up,The follow-up interval is 2 years.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Erwei Song, Ph.D、Sun Yat-Sen Memerial Hospital of Sun Yat-Sen University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年6月1日

初级完成 (预期的)

2018年6月1日

研究完成 (预期的)

2018年6月1日

研究注册日期

首次提交

2016年1月8日

首先提交符合 QC 标准的

2016年1月12日

首次发布 (估计)

2016年1月15日

研究记录更新

最后更新发布 (估计)

2016年10月13日

上次提交的符合 QC 标准的更新

2016年10月12日

最后验证

2016年10月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅