Pulmonary EmbolismNILEXNCT06135220
Non-invasive Diagnosis of Pulmonary Embolism by Use of Biomarkers in Exhaled Breath
An observational study of Pulmonary Embolism, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
In this study, a new, non-invasive method for diagnosis of pulmonary embolism (PE) will be tested. In pre-clinical studies, the investigators have identified 151 putative biomarkers for pulmonary embolism in the exhaled breath, and several of these were also found in a first in-human clinical study what the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- New method for diagnosis of pulmonary embolism (PE) in order to validate/consolidate 151 putative identified biomarkers for PE in the exhaled breath.
- How many people
- 88 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Jan 2024to 31 Dec 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: It is expected that 30 patients with confirmed PE, 30 patients with suspected PE, but where diagnostic work-up did not confirm PE and 30 healthy controls will be included in the study over a one-year period.
Who may be able to join
- Same gender and age (within a 10-year range) as an included PE patient.
- Are conscious and able to understand the given study information.
- Possess legal capacity.
- Age above 18 years.
- Informed, signed consent is obtained.
Who cannot join
- Active malignant disease (i.e., ongoing anti-cancer therapy or palliation).
- Current smokers.
Trial locations and contacts
1 site in 1 country.
About this study
In this study, a new, non-invasive method for diagnosis of pulmonary embolism (PE) will be tested.
In pre-clinical studies, the investigators have identified 151 putative biomarkers for pulmonary embolism in the exhaled breath, and several of these were also found in a first in-human clinical study what the investigators performed in 2019-2020 (DOI 10.1088/1752-7163/ad0aaa). These biomarkers need consolidation in a clinical setting using an updated collection device and proteomic analysis platform before development of a prototype and further test of this new diagnostic method.
Read the detailed description
The study will compare the protein profiles of exhaled breath from patients admitted to the Emergency Care Center with suspected pulmonary embolism and controls with same age (within a range of 10 years) and gender. The main-outcome (i.e., means of the relative amounts of specific proteins in the exhaled breath samples) will be compared by unpaired t-tests after assessment of normality and standard deviations within the two groups (PE patients and controls). Furthermore, sensitivity and specificity will be calculated for relevant proteins. The results from analysis of exhaled breath samples from the patients and controls will be compared with results from the porcine model and the first clinical study to confirm and reduce the number of putative biomarkers for PE.
Blood samples (i.e. excess plasma from routine blood samples drawn as a part of routine diagnostic work-up) from the study participants will be stored for standardization of the putative markers and verification and supplementing analysis of the exhaled breath markers. In order to qualify the most suitable markers and substrates for standardization, the analysis of the exhaled breath samples must be completed before the blood samples can be analyzed. Only biochemical, no genetic analysis will be conducted.
- Conditions
- Pulmonary Embolism
- Being tested
- New method for diagnosis of pulmonary embolism (PE) in order to validate/consolidate 151 putative identified biomarkers for PE in the exhaled breath.
- Keywords
- Breath test, Proteins, Biomarkers
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New method for diagnosis of pulmonary embolism (PE) in order to validate/consolidate 151 putative identified biomarkers for PE in the exhaled breath.Diagnostic test
Also called The exhaled breath will be collected by use of SensAbues which is a commercially available device for the purpose of the collection of proteins from exhaled breath.
The collection time will be an average of 7 minutes. As the patient breathes through a mouthpiece, the exhaled breath is lead through the collection device, and an indicative amount af the exhaled air is led into a clear plastic bag. When the plastic bag is fully inflated, it indicates that the minimum required amount of exhaled breath (approximately 30 liters) has passed through the filter.
| Study group | Role | What they receive |
|---|---|---|
| PE confirmed | Patients admitted with confirmed pulmonary embolism. Receives: Diagnostic Test: New method for diagnosis of pulmonary embolism (PE) in order to validate/consolidate 151 putative identified biomarkers for PE in the exhaled breath. | |
| PE suspected | Patients admitted with suspected, but not confirmed pulmonary embolism. Receives: Diagnostic Test: New method for diagnosis of pulmonary embolism (PE) in order to validate/consolidate 151 putative identified biomarkers for PE in the exhaled breath. | |
| Controls | Healthy controls - same gender and age (within af range of 10 years) as PE patients. Receives: Diagnostic Test: New method for diagnosis of pulmonary embolism (PE) in order to validate/consolidate 151 putative identified biomarkers for PE in the exhaled breath. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of exhaled pulmonary embolism-specific proteins
The primary outcome is diagnosis of pulmonary embolism by use of one or more novel protein biomarkers in the exhaled breath. The investigators will use semiquantitative analysis to identify the most suitable bomarkers already published: DOI: 10.3390/jcm10215165
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start11 Jan 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Principal investigator, Inger Lise Gade, Aalborg University Hospital
- Investigators
- Inger L Gade, MD., Ph.D., Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135220
- Sponsor's protocol ID
- ILG-PE-2024
- Other IDs
- 108272
- Acronym
- NILEX
- Status last verified
- Feb 2024
- First submitted
- 13 Nov 2023
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Diagnosis of Pulmonary Embolism by Use of Biomarkers in Exhaled Breath
- ClinicalTrials.gov ID
- NCT06135220
- Acronym / sponsor ID
- NILEX / ILG-PE-2024
- Conditions
- Pulmonary Embolism
- Keywords
- Breath test, Proteins, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 18 Nov 2023 (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.
In this study, a new, non-invasive method for diagnosis of pulmonary embolism (PE) will be tested.
In pre-clinical studies, the investigators have identified 151 putative biomarkers for pulmonary embolism in the exhaled breath, and several of these were also found in a first in-human clinical study what the investigators performed in 2019-2020 (DOI 10.1088/1752-7163/ad0aaa). These biomarkers need consolidation in a clinical setting using an updated collection device and proteomic analysis platform before development of a prototype and further test of this new diagnostic method.
Detailed description
The study will compare the protein profiles of exhaled breath from patients admitted to the Emergency Care Center with suspected pulmonary embolism and controls with same age (within a range of 10 years) and gender. The main-outcome (i.e., means of the relative amounts of specific proteins in the exhaled breath samples) will be compared by unpaired t-tests after assessment of normality and standard deviations within the two groups (PE patients and controls). Furthermore, sensitivity and specificity will be calculated for relevant proteins. The results from analysis of exhaled breath samples from the patients and controls will be compared with results from the porcine model and the first clinical study to confirm and reduce the number of putative biomarkers for PE.
Blood samples (i.e. excess plasma from routine blood samples drawn as a part of routine diagnostic work-up) from the study participants will be stored for standardization of the putative markers and verification and supplementing analysis of the exhaled breath markers. In order to qualify the most suitable markers and substrates for standardization, the analysis of the exhaled breath samples must be completed before the blood samples can be analyzed. Only biochemical, no genetic analysis will be conducted.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PE confirmed | – | Diagnostic Test: New method for diagnosis of pulmonary embolism (PE) in order to validate/consolidate 151 putative identified biomarkers for PE in the exhaled breath.Patients admitted with confirmed pulmonary embolism. |
| PE suspected | – | Diagnostic Test: New method for diagnosis of pulmonary embolism (PE) in order to validate/consolidate 151 putative identified biomarkers for PE in the exhaled breath.Patients admitted with suspected, but not confirmed pulmonary embolism. |
| Controls | – | Diagnostic Test: New method for diagnosis of pulmonary embolism (PE) in order to validate/consolidate 151 putative identified biomarkers for PE in the exhaled breath.Healthy controls - same gender and age (within af range of 10 years) as PE patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- It is expected that 30 patients with confirmed PE, 30 patients with suspected PE, but where diagnostic work-up did not confirm PE and 30 healthy controls will be included in the study over a one-year period.
Key inclusion criteria (5 listed)
- Same gender and age (within a 10-year range) as an included PE patient.
- Are conscious and able to understand the given study information.
- Possess legal capacity.
- Age above 18 years.
- Informed, signed consent is obtained.
Key exclusion criteria (2 listed)
- Active malignant disease (i.e., ongoing anti-cancer therapy or palliation).
- Current smokers.
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 |
|---|---|---|
| New method for diagnosis of pulmonary embolism (PE) in order to validate/consolidate 151 putative identified biomarkers for PE in the exhaled breath.Also: The exhaled breath will be collected by use of SensAbues which is a commercially available device for the purpose of the collection of proteins from exhaled breath.The collection time will be an average of 7 minutes. As the patient breathes through a mouthpiece, the exhaled breath is lead through the collection device, and an indicative amount af the exhaled air is led into a clear plastic bag. When the plastic bag is fully inflated, it indicates that the minimum required amount of exhaled breath (approximately 30 liters) has passed through the filter. | Diagnostic test | Controls, PE confirmed, PE suspected |
Primary outcome
Amount of exhaled pulmonary embolism-specific proteins
Time frame: 1-2 years
The primary outcome is diagnosis of pulmonary embolism by use of one or more novel protein biomarkers in the exhaled breath. The investigators will use semiquantitative analysis to identify the most suitable bomarkers already published: DOI: 10.3390/jcm10215165
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- 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.
Inger L Gade, MD., Ph.D. principal investigator
Aalborg University Hospital
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 Pulmonary Embolism, run by Aalborg University Hospital at 1 site in Denmark.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 13 Jan 2025. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of exhaled pulmonary embolism-specific proteins (time frame: 1-2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2025.