Ignite Creation Date:
2024-05-06 @ 5:41 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05395611
Status:
RECRUITING
Last Update Posted:
2022-05-27
First Post:
2022-05-10
Brief Title:
Exhaled Breath Particles in Lung Cancer
Sponsor:
Lund University Hospital
Organization:
Lund University Hospital
Study Overview
Official Title:
Exhaled Breath Particles as Biomarkers for Diagnosing Prognosticating and Evaluating of Non Small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 EBPPFR 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
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 EBPPFR 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None