Circulating Tumor Cells Identification in Advanced Stage Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Identification of circulating tumor cells in locally advanced, and metastatic non-small cell lung cancer.
研究概览
简要总结
TITLE : Circulating tumor cells identification in advanced stage non-small cell lung cancer (CIRCUBRONCH)
BACKGROUND : Circulating tumor cells identification is a new field of research in oncology, and some studies have been conducted with success on breast and prostate cancer. Nearly 80% of lung cancers are diagnosed in an advanced stage (IIIB, and IV). Circulating tumor cells identification and monitoring these cells after treatment could help the clinicians to detect relapse or be a prognostic factor.
PRIMARY OBJECTIVE : Circulating tumor cells identification, and monitoring in advanced stage lung cancers (IIIB and IV).
SECONDARY OBJECTIVES : Predictive value of the monitoring of circulating tumor cells on the therapeutic response. Prognostic value of identification of circulating tumor cells at the time of diagnosis.
STUDY DESIGN : This study is a prospective, monocentrique trial analyzing the identification of circulating tumor cells in stage IIIB, and IV non-small cell lung cancers.
Duration of the inclusions: 54 months.
Duration of the study: 66 months.
PROCEDURES : Detection of circulating tumor cells with CellSearch system (Veridex), and a cut-off of 5 cells/7,5 ml of blood.
SAMPLE SIZE : 200 patients
STATISTICAL ANALYSIS : Detection of circulating tumor cells is predicted in 20% of stage IIIB, and IV non-small cell lung cancers included in this study. The cut-off is 5 circulating tumor cells per 7,5 ml of blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced stage NSCLC (stages IIIB, and IV) with measurable or evaluable disease at diagnosis.
- •Age ≥ 18 years.
- •Measurable or evaluable disease according to RECIST criteria.
- •Ability to sign informed consent.
排除标准
- •Prior cancers within 5 years, except for non-melanoma skin cancers, and in situ cervical cancers.
- •Prior chemotherapy, radiation or surgery for lung cancer.
- •Inability to comply with study and/or follow-up procedures.
结局指标
主要结局
Identification of circulating tumor cells in locally advanced, and metastatic non-small cell lung cancer.
时间窗: 18 months
Circulating tumor cells will be search with the Veridex method, and a value per 7.5 f blood will be recorded.
次要结局
- Identification of a cellular profile according to clinical factors (sex,histology, …).(18 months)