Retrospective Study of Molecular Predictors of Sensitivity and Resistance to Pemetrexed in Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Association of each biomarker with treatment outcome in terms of response rate, time to progression, overall survival.
研究概览
简要总结
Present study is aimed at investigating potential molecular predictors of sensitivity or resistance to single-agent pemetrexed in the ≥ second line setting in a large cohort of advanced non-small cell lung cancer (NSCLC) patients. The following biomarkers will be investigated with either immunohistochemistry, fluorescence in situ hybridization or genotyping: thymidylate synthase (TS), dihydrofolate reductase (DHFR), glycinamide ribonucleotide formyl transferase (GARFT), aminoimidazole carboxamide ribonucleotide formyltransferase (ATIC/AICARFT), epidermal growth factor receptor (EGFR), Kirsten rat sarcoma 2 viral oncogene homolog (KRAS), v-myc myelocytomatosis viral oncogene homolog (MYC) and phosphoinositide-3-kinase, catalytic, alpha polypeptide (PIK3CA).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Histologically confirmed diagnosis of advanced non-small cell lung cancer - Tumor tissue available at our institution
- •Patients treated with single agent pemetrexed for metastatic disease
- •Availability of full clinical data
排除标准
- •Cytological diagnosis of advanced Non-small cell lung cancer
- •Lack of tumor tissue at our institution
- •Lack of full clinical data
结局指标
主要结局
Association of each biomarker with treatment outcome in terms of response rate, time to progression, overall survival.
时间窗: one year
次要结局
- Association of each biomarker with clinico-pathological features: histology, gender, age, smoking status, response to previous chemotherapy.(one year)
研究者
Armando Santoro, MD
MD
Istituto Clinico Humanitas