A Clinico-biological Database of Lung Cancers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Objective response rate assessed by CT scan
研究概览
简要总结
This prospective, single-center, interventional study is conducted in order to achieve a biological bank accompanied by clinical data. Blood samples, optional tumor tissue and fecal samples are collected, processed and banked for all the included subjects. Those samples are collected before the start of treatment, at the time of first tumor assessment, at the time of first and second disease progression. The subjects are treated according to standard of care.
Clinical data are collected at each sampling time. The primary objective of the study is to identify biological, clinical and tumoral factors associated with tumor response according SOC treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented new diagnosis of lung cancer by histology or cytology, or lung tumor leading to lung cancer suspicion without diagnosis for which an antineoplastic treatment is indicated
- •Indication of a treatment by surgery, chemotherapy, radio-chemotherapy, radiotherapy or targeted therapy as first line of lung cancer treatment
- •ability of the subject to follow study procedures
- •Age > 18 years
- •Subject must have at least one measurable and/or assessable lesion in regard with RECIST 1.1 criteria
- •Subject is registered with a social security scheme
- •Subject is taken in charge at Pneumology department of Lille UH
- •Subject has signed an informed consent form
排除标准
- •Patient with a history of treatment by antineoplastic chemotherapy, radio-chemotherapy, radiotherapy or targeted therapy, or presenting a contra indication to antineoplastic treatment administration
- •Subject is not willing to sign the informed consent form
- •Subject is not registered with a social security scheme
- •Subject is not francophone
- •Subject is deprived of his/her liberty or under trusteeship
结局指标
主要结局
Objective response rate assessed by CT scan
时间窗: 8 weeks
Assessment of tumor response to SOC treatment, using RECIST 1.1 criteria (partial response defined as a decrease of at least 30% in size of target lesions, complete response defined as a disappearance of all lesions)
次要结局
- Progression-free survival(8 weeks)
- treatment toxicity(8 weeks)
- Disease progression rate assessed by CT scan(8 weeks)
- Overall survival(1 year)