Molecular Profiling in Small Cell Lung Cancer (MPSCLC)
Prospective Molecular Profiling in Small Cell Lung Cancer
研究概览
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
注册 (预期的)
联系人和位置
学习地点
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Guangzhou、中国、510282
- 招聘中
- Zhujiang Hospital
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接触:
- Qiongyao Wang
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首席研究员:
- Linlang Guo
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
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
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
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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.
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Five years
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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
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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).
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Five years
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合作者和调查者
合作者
调查人员
- 首席研究员:Linlang Guo、ZhuJiang Hostipal
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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