Lung CancerNCT05395611
Exhaled Breath Particles in Lung Cancer
An observational study of Lung Cancer and Non-small Cell Lung Cancer, run by Lund University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Lung Cancer, Non-small Cell Lung Cancer, Lung Adenocarcinoma
- What is being tested?
- EBPcollected using the PExA device.
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- 23 Jan 2018to Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with primary lung cancer and listed for tumor resection. Patients without lung cancer.
Who may be able to join
- 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
Who cannot join
- Dementia
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Skåne University Hospital
Lund, Skåne County, 224 60
Sandra Lindstedt, MD, PhD, 0737220580, sandra.lindstedt_ingemansson@med.lu.se
About this study
Official title: Exhaled Breath Particles as Biomarkers for Diagnosing, Prognosticating and Evaluating of Non Small Cell Lung Cancer
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.
Read the 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 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.
- Being tested
- EBPcollected using the PExA device.
- Keywords
- Exhaled Breath Particles, PExA, Lung cancer, Non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBPcollected using the PExA device.Other
The PExA device is a non invasive device that collect particles in exhaled air
| Study group | Role | What they receive |
|---|---|---|
| Lung cancer | 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 Receives: Other: EBPcollected using the PExA device. | |
| Control | 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. Receives: Other: EBPcollected using the PExA device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein concentration in exhaled breath particles (EBP)
EBPs are collected on membranes and analyzed in regards to protein concentration and abundance
Measured: 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
Measured: 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
Measured: In patients without NSCLC (control cohort). (0- 2 weeks)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Before surgery for NSCLC
Protein expression in plasma
Concentration and composition of proteins will be measured in plasma from lung cancer patients
Measured: 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
Measured: 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.
Measured: During surgery for NSCLC. (0- 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start23 Jan 2018
- Primary completionJan 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra Lindstedt, MD, PhD, Principal investigator, Region Skåne, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395611
- Sponsor's protocol ID
- PExCaP
- Status last verified
- Feb 2022
- First submitted
- 10 May 2022
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31994907Broberg 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.
PubMed 31615381Behndig 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.
PubMed 31558154Broberg 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.
PubMed 32055633
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exhaled Breath Particles as Biomarkers for Diagnosing, Prognosticating and Evaluating of Non Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05395611
- Acronym / sponsor ID
- PExCaP
- Keywords
- Exhaled Breath Particles, PExA, Lung cancer, Non-small cell lung cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung cancer | – | Other: EBPcollected using the PExA device.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 |
| Control | – | Other: EBPcollected using the PExA device.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. |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with primary lung cancer and listed for tumor resection. Patients without lung cancer.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- Dementia
- Severe neurological disease
- Drug abuse
- Heart failure New York Heart Association (NYHA) Classification, NYHA class III or IV
- Ejection fraction < 50 %
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EBPcollected using the PExA device.The PExA device is a non invasive device that collect particles in exhaled air | Other | Control, Lung cancer |
Primary outcome
Protein concentration in exhaled breath particles (EBP)
Time frame: Before surgery for NSCLC
EBPs are collected on membranes and analyzed in regards to protein concentration and abundance
Protein concentration in exhaled breath particles (EBP)
Time frame: After surgery for NSCLC (2 weeks - 36 months)
EBPs are collected on membranes and analyzed in regards to protein concentration and abundance
Protein concentration in exhaled breath particles (EBP)
Time frame: In patients without NSCLC (control cohort). (0- 2 weeks)
EBPs are collected on membranes and analyzed in regards to protein concentration and abundance
7 secondary outcomes
Particle flow rate (PFR) expressed as particles/liter of exhaled air
Time frame: Before surgery for NSCLC
Particle flow rate (PFR) expressed as particles/liter of exhaled air
Time frame: After surgery for NSCLC (2 weeks - 36 months)
Particle flow rate (PFR) expressed as particles/liter of exhaled air
Time frame: In patients without NSCLC (control cohort). (0- 2 weeks)
Protein expression in plasma
Time frame: Before surgery for NSCLC
Protein expression in plasma
Time frame: After surgery for NSCLC (2 weeks - 36 months)
Protein expression in plasma
Time frame: In patients without NSCLC (control cohort). (0- 2 weeks)
Protein expression in tissue
Time frame: During surgery for NSCLC. (0- 2 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Background: PubMed 31994907Stenlo 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.
- Background: PubMed 31615381Broberg 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.
- Background: PubMed 31558154Behndig 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.
- Background: PubMed 32055633Broberg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Lindstedt, MD, PhD principal investigator
Region Skåne, Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Non-small Cell Lung Cancer, run by Lund University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra Lindstedt, MD, PhD (+46737220580, sandra.lindstedt_ingemansson@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein concentration in exhaled breath particles (EBP) (time frame: Before surgery for NSCLC). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05395611, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.