Non-invasive Diagnosis of Pulmonary Embolism by Use of Biomarkers in Exhaled Breath

NCT06135220 | Completed DMC

• 2 other identifiers: ILG-PE-2024108272
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Pulmonary Embolism

Keywords

Breath test; Proteins; Biomarkers

Outcome Measures

Primary Outcomes (1)

• 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

  1-2 years

Study Arms (3)

PE confirmed

Patients admitted with confirmed pulmonary embolism.

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.

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.

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.

Interventions

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

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.

Also known as: 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.

Controls; PE confirmed; PE suspected

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Active malignant disease (i.e., ongoing anti-cancer therapy or palliation).
• Current smokers.

Sponsors & Collaborators

• Aalborg University Hospital: lead
• University of Aarhus: collaborator

Study Sites (1)

Aalborg University Hospital

Aalborg, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

1. Exhaled breath 2. Plasma

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Inger L Gade, MD., Ph.D.

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Registrar, MD, PhD

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: January 11, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 13, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)