Exploring Cancer Evolution, Prognostic and Predictive Biomarkers in EGFR-mutant NSCLC
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Intratumor heterogeneity (ITH)
研究概览
简要总结
To investigate genomic architecture, cancer evolution and their relationship with clinical outcomes in EGFR-mutant NSCLC.
详细描述
EGFR mutations are detected in about 50% of East Asian NSCLC and 10% of Western NSCLC. EGFR-mutant NSCLC harbors distinct genomic architecture including high ITH, early diversification, genome instability, low background mutation rates. But despite its high ITH, EGFR-mutant NSCLC usually have better prognosis than NSCLC with other driver mutations even without the application of targeted therapies, indicating that EGFR mutations may have distinct impacts on cancer evolution. This study intends to investigate the genomic architecture, cancer evolution trajectories and their relationship with clinical outcomes in EGFR-mutant NSCLC, and to identify prognostic and predictive biomarkers for this population that could potentially guide therapeutic decisions and improved clinical outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older
- •Histologically or cytologically confirmed non-small-cell lung cancer
- •ECOG PS=0-2
- •EGFR mutations confirmed by tissue or peripheral blood
- •Can provide tumor tissue samples (fresh or archived)
- •The subject should have good compliance, who would participate in the research voluntarily, and sign the informed consent
排除标准
- •History of other malignancies within 5 years (excluding basal cell carcinoma of the skin or other carcinoma in situ that has been resected).
- •Unable to provide sufficient tumor tissue for analysis.
- •Subjects with active, unstable systemic diseases, such as active infection, uncontrolled hypertension, heart failure (NYHA class >= II), unstable angina pectoris, acute coronary syndrome, severe arrythmia, severe liver, kidney or metabolic diseases, HIV infection.
- •Subjects who are deemed unable to comply with the study requirements or complete the study.
结局指标
主要结局
Intratumor heterogeneity (ITH)
时间窗: 5 years
Intratumor heterogeneity in terms of genomic architecture, transcriptomic profiles and clonal composition; Investigate the relationship between ITH, clinical features and clinical outcomes in EGFR-mutant NSCLC
次要结局
- Clinical utility of ctDNA in EGFR-mutant NSCLC(5 years)
研究者
Li Zhang, MD
Chief of Medical Oncology Department
Sun Yat-sen University