Towards Better Therapy for Resectable Lung Cancer: Metabolomics Predict Therapy Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 7
- 主要终点
- The metabolic profile in plasma measured by Nuclear Magnetic Resonance (NMR)
研究概览
简要总结
Complete resection is the mainstay of treatment for stage I-IIIA resectable non-small cell lung cancer (NSCLC). However rates of recurrence of disease are high, with five-year survival rates ranging between 73% (stage IA) and 24% (stage IIIA). Therefore, a prognostic biological marker that stratifies between NSCLC patients whom surgery cures versus patients in whom surgery would be futile due to early disease relapse after surgery is eagerly awaited.
The primary objective of this prospective study is to establish a prognostic marker of early disease progression after complete surgical resection in patients with stages I to IIIA NSCLC. For this purpose the investigator will compare the metabolic profile with disease progression or death within one year after complete surgical resection to the patients with a progression free survival. Furthermore the investigator will evaluate the changes in the metabolic profile after surgery and if changes in this metabolic profile over time can predict disease recurrence before it becomes clinically apparent.
详细描述
Introduction: Precision medicine relies on validated biomarkers that can accurately classify patients by their probable disease risk, prognosis and/or response to treatment. Metabolomics is particularly promising for biomarker development because altered metabolism is considered a hallmark of cancer. The measurement of the metabolomic plasma profile is cheap (+-50 EUR) and fast (+-17 min), with a high information throughput on a per sample base.
Rationale: Complete resection is the mainstay of treatment for stage I-IIIA resectable non-small cell lung cancer (NSCLC). However rates of recurrence of disease are high, with five-year survival rates ranging between 73% (stage IA) and 24% (stage IIIA). Therefore, a prognostic biological marker that stratifies between NSCLC patients whom surgery cures versus patients in whom surgery would be futile due to early disease relapse after surgery is eagerly awaited.
Study objective: The primary study hypothesis is that the metabolic plasma profile is a predictive marker of early disease progression after complete surgical resection in patients with pathological stages I to IIIA NSCLC. The secondary study hypothesis is that the level of dissimilarity between the metabolic profile before surgery and the metabolic profile after surgery, is a predictor for disease recurrence (in which the extreme case would be, that a normalization of the metabolic profile to the profile of a healthy person, is indicative of a good prognosis).
Study design: Prospective, interventional design
Study population: Stage I-IIIA NSCLC patients who will undergo complete surgical resection willing to provide a written informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •Patients with a stage I-IIIA NSCLC tumor, eligible to undergo surgery
- •Signed written informed consent
排除标准
- •No fasting starting from 22:00 h the day prior to blood sampling
- •Medication intake in the morning of the blood sampling
- •Non-controlled diabetes
- •History of cancer during the past 5 years
- •Treatment for cancer during the past 5 years
结局指标
主要结局
The metabolic profile in plasma measured by Nuclear Magnetic Resonance (NMR)
时间窗: baseline
The metabolic profile in plasma measured by Nuclear Magnetic Resonance (NMR) spectroscopy predicts disease disease recurrence within one year after surgical resection.
次要结局
- Correlation between presence or absence Hotspot mutations and the metabolic profile in plasma(day 1, week 12, week 52)
- Change in the metabolic profile in plasma measured by Nuclear Magnetic Resonance (NMR)(screening, day 1, week 1, week 4, week 6, week 12, week 52)
- Change in ctDNA mutations in plasma(day 1, week 12, week 52)
- Metabolic profile of the primary tumor(day 1)
研究者
Prof. dr. Michiel Thomeer
Head of department of respiratory medicine
Hasselt University