Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-27 @ 6:14 AM
Study NCT ID:
NCT04010760
Status:
COMPLETED
Last Update Posted:
2022-02-15
First Post:
2019-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-invasive Diagnosis of Pulmonary Embolism by Use of Biomarkers in Exhaled Breath Condensate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011655', 'term': 'Pulmonary Embolism'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '1. Exhaled breath condensate (EBC)\n2. Plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-14', 'studyFirstSubmitDate': '2019-07-04', 'studyFirstSubmitQcDate': '2019-07-04', 'lastUpdatePostDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prediction of pulmonary embolism by use of biomarkers in the EBC', 'timeFrame': '1-2 years', 'description': 'The primary outcome is prediction of pulmonary embolism by use of one or more novel biomarkers in the EBC.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Embolism']}, 'referencesModule': {'references': [{'pmid': '37939397', 'type': 'DERIVED', 'citation': 'Gade IL, Riddersholm SJ, Stilling-Vinther T, Brondum RF, Bennike TB, Honore B. A clinical proteomics study of exhaled breath condensate and biomarkers for pulmonary embolism. J Breath Res. 2023 Nov 17;18(1). doi: 10.1088/1752-7163/ad0aaa.'}]}, 'descriptionModule': {'briefSummary': 'In this study, a new, non-invasive method for diagnosis of pulmonary embolism (PE) will be tested. In pre-clinical studies, we have identified 151 putative biomarkers for pulmonary embolism in the exhaled breath condensate (EBC). These biomarkers needs validation/consolidation in a clinical setting before further test of this new diagnostic method.', 'detailedDescription': 'The study will compare the protein profiles of EBC collected from patients admitted to the department of cardiology with suspected pulmonary embolism and controls with same age (within a range of 10 years) and gender from the outpatient clinic awaiting elective cardiovascular surgery. The main-outcome (i.e. means of the relative amounts of specific proteins in the EBC samples) will be compared by unpaired t-tests after assessment of normality and standard deviations within the three groups (PE confirmed, PE suspected but not confirmed and controls). Furthermore, sensitivity and specificity will be calculated for relevant proteins. The results from analysis of EBC samples from the patients and controls will be compared with results from the porcine model in order 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 EBC markers. In order to qualify the most suitable markers and substrates for standardization, the analysis of the EBC samples must be completed before the blood samples can be analyzed. Only biochemical, no genetic analysis will be conducted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'It is expected that\n\n* 40 patients with confirmed PE,\n* 40 patients with suspected PE, but where diagnostic work-up did not confirm PE and\n* 40 healthy controls\n\nwill be included in the study over a six-month period.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria - Suspected/confirmed PE patients:\n\n* Admitted to the emergency department with initial diagnosis of PE, visited to the Department of Cardiology at Aalborg University Hospital.\n* Are conscious and able to understand the given study information.\n* Possess legal capacity.\n* Age above 18 years.\n* Informed, signed consent is obtained.\n* Clinically stable, which is defined as patients with stable blood pressure and not in need for other treatments .\n* No need for organ support, which comprises need for vasopressors or inotropes, mechanical ventilation, extra corporal circulation or renal replacement therapy.\n\nInclusion Criteria - Controls:\n\n• Patients as the PE patients, but where the diagnosis of PE is rejected.\n\nThe rest of the control persons will be recruited as described:\n\n* Patients who are going to have elective procedures at the Department of Cardiology, Aalborg University Hospital.\n* Same gender and age (within a 10-year range) as an included PE patient.\n* Are conscious and able to understand the given study information.\n* Possess legal capacity.\n* Age above 18 years.\n* Informed, signed consent is obtained.\n\nExclusion Criteria:\n\n* Active malignant disease (i.e. ongoing anti-cancer therapy or palliation).\n* Current smokers'}, 'identificationModule': {'nctId': 'NCT04010760', 'briefTitle': 'Non-invasive Diagnosis of Pulmonary Embolism by Use of Biomarkers in Exhaled Breath Condensate', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University Hospital'}, 'officialTitle': 'Non-invasive Diagnosis of Pulmonary Embolism by Use of Biomarkers in Exhaled Breath Condensate', 'orgStudyIdInfo': {'id': 'ILG-PE-2018'}, 'secondaryIdInfos': [{'id': '#0053310', 'type': 'OTHER_GRANT', 'domain': 'The Novo Nordisk Foundation'}, {'id': 'N-20180086', 'type': 'OTHER', 'domain': 'Den Videnskabsetiske Komite for Region Nordjylland'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'PE confirmed', 'description': 'Patients admitted with confirmed pulmonary embolism.', 'interventionNames': ['Diagnostic Test: Test of biomarkers for PE in EBC']}, {'label': 'PE suspected', 'description': 'Patients admitted with suspected, but not confirmed pulmonary embolism.', 'interventionNames': ['Diagnostic Test: Test of biomarkers for PE in EBC']}, {'label': 'Controls', 'description': 'Healthy controls same gender and age (within af range of 10 years) as PE patients', 'interventionNames': ['Diagnostic Test: Test of biomarkers for PE in EBC']}], 'interventions': [{'name': 'Test of biomarkers for PE in EBC', 'type': 'DIAGNOSTIC_TEST', 'description': 'New method for diagnosis of pulmonary embolism (PE) in order to validate/consolidate 151 putative identified biomarkers for PE in the exhaled breath condensate (EBC).\n\nThe EBC will be collected by use of the RTube(R) system which has been used in previous studies of EBC. As the patient breathes through a mouth piece, the exhaled breath is led through a cooling chamber where the vaporous part of the exhaled breath condenses.\n\nWe aim at collecting a total minimum of 3.0 mL EBC per study subject in order to have a sufficient amount of protein for the subsequent analysis. We aim at collecting exhaled breath condensate for 2\\*15 minutes with the possibility to stop the collection after less than 15 minutes if the volume is sufficient.', 'armGroupLabels': ['Controls', 'PE confirmed', 'PE suspected']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Aalborg Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}], 'overallOfficials': [{'name': 'Inger L Gade, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aalborg University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Aarhus', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Registrar', 'investigatorFullName': 'Inger Lise Gade', 'investigatorAffiliation': 'Aalborg University Hospital'}}}}