Lung Cancer Early Molecular Assessment Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 1,297
- 试验地点
- 1
- 主要终点
- The percentage of patients with EGFR mutation or ALK translocation using the combined tumour tissue and liquid biopsy analysis
研究概览
简要总结
The investigators hypothesize that an early molecular profiling, that includes both tissue and blood-bases analysis, for all NSCLC patients, including stage I-III, will increase diagnostic efficiency. When molecular profiles are available at an earlier stage of disease, more patients will benefit from personalized therapy once needed. This will result in both a better quality of life and outcome.
详细描述
In this prospective multicentre trial tumours of all patients presenting with NSCLC will be profiled upfront, irrespective of disease stage and pathology using both tissue and blood-based genetic testing. A minimal molecular profiling is depicted but other targets will be included in due time. The study is divided in two parts. In the first part participating centres will have a run-in period of half a year in which molecular profiling is performed as is currently standard of care. This period will be used to measure the impact of increased awareness on the diagnostic process. During the second part of the study a comprehensive upfront profiling according to local standards will take place for all NSCLC patients. Liquid (blood) biopsies will be included in order to increase the diagnostic yield for those patients where tissue biopsies are not adequate. Patients will be treated according to standard of care, or included in clinical studies where appropriate. Re-biopsies (both tissue and liquid) will be advocated at the time of establishing disease progression/disseminated disease, and personalized therapy will be initiated according to the existing data from the molecular profiling.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Suspicion of lung carcinoma or established NSCLC but awaiting start of definitive treatment
- •Written informed consent to undergo diagnostic procedure and molecular analysis of the disease.
排除标准
- •Not motivated to receive any treatment at any point in time. Patients who consider undergoing treatment in the future are eligible.
结局指标
主要结局
The percentage of patients with EGFR mutation or ALK translocation using the combined tumour tissue and liquid biopsy analysis
时间窗: 3 years
Patients with EGFR mutation or ALK translocation using the combined tumour tissue and liquid biopsy analysis
次要结局
- The influence of the liquid biopsies on the diagnostic yield of tissue molecular and pathological analysis.(3 years)
- Include the test performance of both techniques in different stage of disease(3 years)
- The percentage of patients with a predefined actionable genetic alteration(3 years)
- The costs(3 years)