Association of Bone and Metabolic Parameters With Overall Survival in Patients With Bone Metastases From Adenocarcinoma Lung Cancer (POUMOS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- serum DKK1
研究概览
简要总结
Mortality due to non small cell lung cancers is the first cause of cancer death in men around the world. Lung adenocarcinoma regularly induces bone metastases responsible for high morbidity and impaired life quality. Overall survival of these patients is poor. Thus the investigators aimed to identify if some bone and metabolic parameters were associated with overall survival.
Patients and Methods POUMOS is a prospective cohort of patients suffering from adenocarcinoma lung cancers with a first bone metastasis (stage IV). All patients have a bone biopsy with molecular status characterization of the tumor for EGFR, KRAS, BRAF and ALK. Bone metastasis localizations are obtained by bone scintigraphy or FDG-PET/CT. Whole body composition is obtained by DEXA scan (Hologic®). The investigators assessed also fasting blood levels of bone and metabolic biomarkers.
Survival analyses will be performed using a proportional hazard regression model.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •adults over 18 years
- •both gender
- •covered by the French National Insurance
- •first bone metastases of adenocarcinoma lung cancer (synchronous or metachrone)
排除标准
- •- adenocarcinoma previously treated by systemic oncologic treatment (chemotherapy, targeted therapy, immunotherapy)
结局指标
主要结局
serum DKK1
时间窗: day 0
Biomarkers are assessed at baseline.
次要结局
- urinary CTX(day 0)
- serum HbA1C(day 0)
- mutational profile of the bone metastases(day 0)
- hip bone mass (g/cm²)(day 0)