Analyse du Profil moléculaire Des Exosomes de la Veine Pulmonaire Dans le Cancer Bronchique de Stade précoce
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Evaluate size distribution, concentration and molecular profiling of pulmonary vein exosomes at inclusion
研究概览
简要总结
This is an observational prospective single-center study of 30 patients operated for early-staged non-small cell lung cancer. The main aim is the analysis of molecular profiling of exosome with a sample in tumor-draining vein in order to identify prognostic molecular characteristics associated with cancer recurrence after surgery.
详细描述
Surgical resection remains the best chance for cure in patients with early-stage non-small-cell lung cancer (NSCLC). Unfortunately, approximately 30-50% of patients will relapse within 5-year of curative surgery despite early TNM-stage. The Identification of prognostic biomarkers of relapse is a necessity. Among them, extracellular vesicles (exosomes) study seems promising in early stage cancers and samples directly in tumor-draining vein to. The pulmonary vein is draining blood directly from the lungs and sampling at this location could provide a higher yield for oncosome. The litterature reports that Navarro et al. are the only team to have link exosome characteristics to oncological outcomes following surgery. The investigators propose to analyze the molecular profiling mediated by these extracellular vesicles in the tumor-draining vein of operated patients.
A peripheral blood sample is recolted before surgery (D-1 or D0). During oncological lung surgery, the pulmonary tumor-drainage vein is first exposed and punctured with a needle prior to subsequent surgical manipulation for resection (D0). A piece of resected tumor will be analyzed for the study (D0). Quantification and size distribution of exosome and molecular cargo of exosome in blood samples (peripheral and pulmonary vein) and tumor are analyzed (DNA sequencing).
Standard clinical and radiological follow-up is then performed and 2-year overall survival and 2-year disease free-survival are checked.
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
- 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
- •- Surgical non-small cell lung cancer with pure solid nodule or part-solid ground glass nodule on CT-scan
排除标准
- •Pure ground glass nodule,
- •Neoadjuvant therapy,
- •Second cancer or cancer in the 5 years,
- •Pregnancy,
- •Patients <18 years-old,
- •Tutorship
研究组 & 干预措施
Blood samples at 2 sites: peripheral vein and tumor-draining vein
D0: surgery (inclusion): oncological lung resection
- Blood samples at 2 sites: peripheral vein and tumor-draining vein
- Resected tumor analysis Standard clinical and radiological follow-up during 2 years (medical consultation or phone call)
干预措施: Blood samples at 2 sites: peripheral vein and tumor-draining vein (Biological)
结局指标
主要结局
Evaluate size distribution, concentration and molecular profiling of pulmonary vein exosomes at inclusion
时间窗: 36 months
Concentration of extracellular vesicule (million of particule/mL of blood)
次要结局
- Size distribution, molecular profiling of peripheral vein exosome sat inclusion(36 months)
- Mutations and polymorphism in resected lung cancer(36 months)
- Overall survival(36 months)
- Two-year disease-free survival(24 months)