Assessment of the Prevalence and Prognostic Value of Gene Molecular Alterations and Association With Clinicopathological Factors in Patients With Non-small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 367
- 试验地点
- 1
- 主要终点
- OS (overall survival) in whole cohort.
研究概览
简要总结
GEMA-proN is an observational, multicenter, single cohort, retrospective clinical trial. The aim of the trial is to assess the prevalence, and prognostic value of genetic molecular alterations and investigate correlations with clinicopathological features in unselected patients with histologically confirmed non-small cell lung cancer (NSCLC).
详细描述
This a non- interventional, multicenter, retrospective one arm trial assessing patients with histologically confirmed diagnosis of non-small cell lung cancer (NSCLC). Patients received treatment in 18 Hellenic Cooperative Oncology Group (HeCOG)- affiliated centers in Greece between 2000 and 2020. Molecular genetic alterations, including single nucleotide variants, copy number alterations, and translocations, are detected with next generation sequencing using the ForeSENTIA® NSCLC panel developed by NIPD Genetics. The aim of the trial is to assess the prevalence and prognostic value of molecular alterations in the study population.
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
- •Age 18 and above.
- •Histologically confirmed non-small cell lung cancer (NSCLC).
- •Adequate, and suitable tissue for the testing of somatic genetic alterations.
排除标准
- •Patients with personal medical history of malignancy, other than non-small cell lung cancer (NSCLC), with the exclusion of completely resected non-melanoma skin cancers, in situ carcinomas of the cervix uteri, in situ bladder carcinomas, in situ ductal breast carcinoma, and other cancers treated with curative intent with no evidence of disease recurrence for 5 years.
结局指标
主要结局
OS (overall survival) in whole cohort.
时间窗: Through study completion, 3 years.
Overall survival is defined from the date of initial diagnosis until death or last contact.
次要结局
- Progression-free survival (PFS) in patients who received 1st line treatment for metastatic non-small cell ling cancer (NSCLC).(Through study completion, 3 years.)
- Recurrence-free survival (RFS) in patients who underwent surgical treatment for non-small cell lung cancer (NSCLC).(Through study completion, 3 years.)