NCT05395611|UnknownDMC
Exhaled Breath Particles in Lung Cancer
Exhaled Breath Particles as Biomarkers for Diagnosing, Prognosticating and Evaluating of Non Small Cell Lung Cancer
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Exhaled Breath Particles as Biomarkers for Diagnosing, Prognosticating and Evaluating of Non Small Cell Lung Cancer
Sponsor study identifier
observational
300
1 country
1
Study Start
January 23, 2018
Actual (reported)Primary Completion
January 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 23, 2018
Actual (reported)May 10, 2022
Actual (reported)May 27, 2022
Actual (reported)January 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Protein concentration in exhaled breath particles (EBP)
EBPs are collected on membranes and analyzed in regards to protein concentration and abundance
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
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
In patients without NSCLC (control cohort). (0- 2 weeks)
Patients with primary non small cell lung cancer listed for tumor resection. EBP, plasma and lung tumor tissue will be collected for protein profiling. Collection of EBP will be done at 2 time points before and after surgery. Collection of plasma will be done at 2 time points before and after surgery. Collection of lung/tumor tissue will be done at the time of surgery
Patients without lung cancer matched according to age and smoking history (control cohort) Collection of EBP will be done at one time point. Collection of plasma will be done at one time point.
The PExA device is a non invasive device that collect particles in exhaled air
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients diagnosed with primary lung cancer and listed for tumor resection. Patients without lung cancer.
Skåne University Hospital
Lund, Skåne County, 224 60, Sweden
Stenlo M, Hyllen S, Silva IAN, Bolukbas DA, Pierre L, Hallgren O, Wagner DE, Lindstedt S. Increased particle flow rate from airways precedes clinical signs of ARDS in a porcine model of LPS-induced acute lung injury. Am J Physiol Lung Cell Mol Physiol. 2020 Mar 1;318(3):L510-L517. doi: 10.1152/ajplung.00524.2019. Epub 2020 Jan 29.
Broberg E, Hyllen S, Algotsson L, Wagner DE, Lindstedt S. Particle Flow Profiles From the Airways Measured by PExA Differ in Lung Transplant Recipients Who Develop Primary Graft Dysfunction. Exp Clin Transplant. 2019 Dec;17(6):803-812. doi: 10.6002/ect.2019.0187. Epub 2019 Oct 11.
Exhaled breath particles (EBP) Blood samples Tumor tissue and surrounding non tumor lung tissue
Sandra Lindstedt, MD, PhD
Region Skåne, Lund University
First Submitted
May 10, 2022
First Posted
May 27, 2022
Study Start
January 23, 2018
Actual (reported)Primary Completion
January 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer
Particle flow rate (PFR) expressed as particles/liter of exhaled air
Before surgery for NSCLC
Particle flow rate (PFR) expressed as particles/liter of exhaled air
After surgery for NSCLC (2 weeks - 36 months)
Particle flow rate (PFR) expressed as particles/liter of exhaled air
In patients without NSCLC (control cohort). (0- 2 weeks)
Protein expression in plasma
Before surgery for NSCLC
Protein expression in plasma
After surgery for NSCLC (2 weeks - 36 months)
Contact the study team to confirm eligibility.
Behndig AF, Mirgorodskaya E, Blomberg A, Olin AC. Surfactant Protein A in particles in exhaled air (PExA), bronchial lavage and bronchial wash - a methodological comparison. Respir Res. 2019 Sep 26;20(1):214. doi: 10.1186/s12931-019-1172-1.
Broberg E, Andreasson J, Fakhro M, Olin AC, Wagner D, Hyllen S, Lindstedt S. Mechanically ventilated patients exhibit decreased particle flow in exhaled breath as compared to normal breathing patients. ERJ Open Res. 2020 Feb 10;6(1):00198-2019. doi: 10.1183/23120541.00198-2019. eCollection 2020 Jan.
Study Completion
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 27, 2022
Record last verified: 2022-02
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Source: ClinicalTrials.gov.
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