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Molecular Profiling in Small Cell Lung Cancer (MPSCLC)

2019年1月18日 更新者:Zhujiang Hospital

Prospective Molecular Profiling in Small Cell Lung Cancer

This protocol is to obtain tumor tissues and blood samples from patients with a confirmed histological diagnosis of Small cell lung cancer(SCLC) for molecular profiling.

研究概览

地位

未知

详细说明

Small cell lung cancer (SCLC) is most invasive subtypes of lung cancer. After diagnosis, the SCLC patients without treatment often die in 2-4 months. SCLC is a highly heterogeneous malignant tumor, the previous treatment principle of the tumor is based on the traditional histopathology, which not provide accurate guidance for precise treatment. In recent years, breakthrough has been made in molecular classification of breast cancer, non-small cell lung cancer, gastrointestinal cancer and of the other tumor, but SCLC molecular classification has not yet reported.

In this prospective study, SCLC tissues and blood samples from extensive SCLC patients will be obtained and evaluated of molecular profiling. Eligible population includes: patients who have not undergone any treatment and diagnosed of extensive SCLC by immunohistochemistry(IHC). The purpose is to evaluate molecular profiling of SCLC patients who are sensitive or resistant to chemotherapy (Cisplatin+Etoposide). To compare molecular alterations of SCLC patients with different prognosis (Overall Survival, Progress Free Survival).

研究类型

观察性的

注册 (预期的)

120

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

      • Guangzhou、中国、510282
        • 招聘中
        • Zhujiang Hospital
        • 接触:
          • Qiongyao Wang
        • 首席研究员:
          • Linlang Guo

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 至 75年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

概率样本

研究人群

Patients have been histologically diagnosed of small cell lung cancer and evaluated with extensive stage.

描述

Inclusion Criteria:

  • Age: between 18 and 75 years old.
  • Sexes Eligible for Study: All
  • Diagnosed of SCLC by IHC, and divided into extensive stage.
  • The ECOG (Eastern Cooperative Oncology Group, ECOG) PS(performance status,PS) Scale score is 0 or 1.
  • At least one measurable lesions by CT scan.
  • Expect to survive for at least three months.
  • Peripheral blood routine and liver and kidney function meet the following criterion (blood draw 7 days before the treatment begins) :
  • The White Blood Cell (WBC) is greater than the 3.0×10^9/L or neutrophils (ANC) more than 1.5 x10^9/L;
  • Hemoglobin (HGB) is greater than 80 g/L.
  • Platelet (PLT) is greater than 100×10^9/L.
  • (AST/ALT): Aspartate aminotransferase/Alanine aminotransferase<3.0 times of normal range.
  • Total bilirubin (TBIL) < 1.5 times of normal range.
  • Creatinine (CREAT) < 1.5 times of normal range.
  • Female or male patients must adopt effective birth control measures.
  • Informed consent forms provided. Patients must meet each of the above criteria.

Exclusion Criteria:

  • Other pathological types of tumors ,rather than small cell lung cancer.
  • Incorporating other tumors in the early diagnosis;
  • Patients who have received chemotherapy, radiotherapy or any other anti-cancer treatment.
  • Patients that known to be allergic to the drug components involved in the study;
  • Patients with severe allergies or allergies;
  • Pregnant or breastfeeding women;
  • Patients with acute infection which is difficult to control;
  • Drug abuse, substance abuse, long-term alcohol and AIDS(Acquired Immune Deficiency Syndrome) patients.

Candidates who meet each of the exclusion criteria will not included in the research.

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

  • 观测模型:队列
  • 时间观点:预期

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Overall survival(OS)
大体时间:Five years
OS is defined as time duration from randomization until the date of death from any cause. If the participants who had survived after the end of the study, or loss of follow-up, their last time of contact is defined as a deadline.
Five years

次要结果测量

结果测量
措施说明
大体时间
Progression-free survival (PFS)
大体时间:Five years
PFS is defined as time duration from randomization until the date of SD(Stable Disease) or PD(Progressed Disease) evaluated by WHO RECIST (World Health Organization Response Evaluation Criteria in Solid Tumors, Edition1.1).
Five 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。

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。

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 (实际的)

2017年5月3日

初级完成 (预期的)

2021年12月31日

研究完成 (预期的)

2021年12月31日

研究注册日期

首次提交

2017年5月5日

首先提交符合 QC 标准的

2017年5月19日

首次发布 (实际的)

2017年5月22日

研究记录更新

最后更新发布 (实际的)

2019年1月22日

上次提交的符合 QC 标准的更新

2019年1月18日

最后验证

2019年1月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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.

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