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.
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.
Study Type
OBSERVATIONAL
Enrollment
300
The PExA device is a non invasive device that collect particles in exhaled air
Skåne University Hospital
Lund, Skåne County, Sweden
RECRUITINGProtein concentration in exhaled breath particles (EBP)
EBPs are collected on membranes and analyzed in regards to protein concentration and abundance
Time frame: Before surgery for NSCLC
Protein concentration in exhaled breath particles (EBP)
EBPs are collected on membranes and analyzed in regards to protein concentration and abundance
Time frame: After surgery for NSCLC (2 weeks - 36 months)
Protein concentration in exhaled breath particles (EBP)
EBPs are collected on membranes and analyzed in regards to protein concentration and abundance
Time frame: In patients without NSCLC (control cohort). (0- 2 weeks)
Particle flow rate (PFR) expressed as particles/liter of exhaled air
Particle flow rate (PFR) has recently been shown to differ significantly between patients suffering from respiratory diseases such as bronchiolitis obliterans syndrome (BOS) and covid-19 compared to healthy controls. PFR will be measured from patients with primary lung cancer and control patients to investigate if PFR can be used to distinguish between the two groups and thus help diagnosing lung cancer in earlier stages.
Time frame: Before surgery for NSCLC
Particle flow rate (PFR) expressed as particles/liter of exhaled air
Particle flow rate (PFR) has recently been shown to differ significantly between patients suffering from respiratory diseases such as bronchiolitis obliterans syndrome (BOS) and covid-19 compared to healthy controls. PFR will be measured from patients with primary lung cancer and control patients to investigate if PFR can be used to distinguish between the two groups and thus help diagnosing lung cancer in earlier stages.
Time frame: After surgery for NSCLC (2 weeks - 36 months)
Particle flow rate (PFR) expressed as particles/liter of exhaled air
Particle flow rate (PFR) has recently been shown to differ significantly between patients suffering from respiratory diseases such as bronchiolitis obliterans syndrome (BOS) and covid-19 compared to healthy controls. PFR will be measured from patients with primary lung cancer and control patients to investigate if PFR can be used to distinguish between the two groups and thus help diagnosing lung cancer in earlier stages.
Time frame: In patients without NSCLC (control cohort). (0- 2 weeks)
Protein expression in plasma
Concentration and composition of proteins will be measured in plasma from lung cancer patients
Time frame: Before surgery for NSCLC
Protein expression in plasma
Concentration and composition of proteins will be measured in plasma from lung cancer patients
Time frame: After surgery for NSCLC (2 weeks - 36 months)
Protein expression in plasma
Concentration and composition of proteins will be measured in plasma from healthy control patients
Time frame: In patients without NSCLC (control cohort). (0- 2 weeks)
Protein expression in tissue
Concentration and composition of proteins will be measured in tumor tissue and the surrounding lung tissue.
Time frame: During surgery for NSCLC. (0- 2 weeks)
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