Exhaled Breath Particles as Biomarkers for Diagnosing, Prognosticating and Evaluating of Non Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Protein concentration in exhaled breath particles (EBP)
研究概览
简要总结
Lung cancer (CaP) is the leading cause of cancer related deaths on a global level. Early diagnosis is vital for survival and life quality of the affected patients, yet lung cancer is often diagnosed at advanced stages, causing poor five-year survival rates. Exhaled breath particles (EBP) and particle flow rate (PFR) collected by the particles in exhaled air (PExA) system is a safe and easily reproducible non-invasive method for gaining insight into the molecular environment of the distal airways. EBP and PFR have been found useful in detection of other airway diseases such as acute respiratory distress syndrome (ARDS), primary graft dysfunction (PGD) and bronchiolitis obliterans syndrome (BOS). It has been shown that particles found in EBP reflect the general composition of respiratory tract lining fluid (RTLF) and that biomarkers found in EBP correlate to proteins that can be found in both bronchoalveolar lavage fluid (BALF) and plasma. Particle flow rate (PFR) has been found to differ between patients with lung cancer compared to control patients. In the present study the investigators aim to collect EBP samples and measure PFR from patients with primary lung cancer and from control patients. EBPs are collected for molecular analysis. The investigators aim to identify biomarkers for diagnosing, predicting prognosis of and evaluating surgical treatment of non small cell lung cancer.
详细描述
EBP samples and measurements of PFR will be collected from patients with primary non-small cell lung cancer (NSCLC) at Skåne University Hospital (SUS) Lund. Measurements will be done at 2 time points, before and after surgical resection for NSCLC.
EBP samples will be collected at one time point from a matched (by age and smoking history) control cohort.
Blood samples will be collected from both cohorts, at the same time points as the EBP/PFR measurements.
Tumor tissue and healthy adjacent lung tissue will be collected from lung cancer patients with tumors greater than 3 cm in diameter on preoperative computed tomography.
The purpose of this clinical trial is to identify non-invasive means of diagnosing NSCLC at earlier stages. The PExA method is not associated with any risks and has potential minimize hospitalization associated with more invasive methods that are in clinical practice today, such as bronchoscopy and biopsies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary lung cancer with clinical Tumor, Node, Metastasis (TNM) up to cT3N1M0 according to TNM 7th edition
- •Able to take instructions and perform the standardized breathing maneuver
排除标准
- •Severe neurological disease
- •Drug abuse
- •Heart failure New York Heart Association (NYHA) Classification, NYHA class III or IV
- •Ejection fraction < 50 %
- •S-creatinine > 140 µmol/L
- •Poorly regulated diabetes mellitus
结局指标
主要结局
Protein concentration in exhaled breath particles (EBP)
时间窗: In patients without NSCLC (control cohort). (0- 2 weeks)
EBPs are collected on membranes and analyzed in regards to protein concentration and abundance
次要结局
- Protein expression in plasma(In patients without NSCLC (control cohort). (0- 2 weeks))
- Particle flow rate (PFR) expressed as particles/liter of exhaled air(In patients without NSCLC (control cohort). (0- 2 weeks))
- Protein expression in tissue(During surgery for NSCLC. (0- 2 weeks))