Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-01-04 @ 5:47 AM
Study NCT ID:
NCT04377958
Status:
COMPLETED
Last Update Posted:
2020-05-08
First Post:
2020-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development and Validation of a Serum Biomarker for the Diagnostic Work-up of Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-06', 'studyFirstSubmitDate': '2020-05-04', 'studyFirstSubmitQcDate': '2020-05-04', 'lastUpdatePostDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum calprotectin', 'timeFrame': 'Day 1', 'description': 'Serum Calprotectin (pg/ml) will be measured in serum samples using a U-plex assay'}], 'secondaryOutcomes': [{'measure': 'Sputum calprotectin', 'timeFrame': 'Day 1', 'description': 'Sputum Calprotectin (pg/ml) will be measured in sputum samples using a U-plex assay'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma', 'Biomarkers']}, 'descriptionModule': {'briefSummary': 'Serum samples of asthmatic patients will be screened for serum biomarkers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 - 65 years\n* physician-diagnosed asthma\n\nExclusion Criteria:\n\n* No clear asthma phenotype\n* Presence of other pulmonary diseases (Chronic obstructive pulmonary disease, alfa-1-antitrypsine deficiency emphysema, Immunoglobulin E deficiency, allergic bronchopulmonary aspergillosis)\n* \\> 15 pack years\n* No sputum available\n* Respiratory infection\n* Other inflammatory diseases (Rheumatoid Arthritis, Colitis Ulcerosa)'}, 'identificationModule': {'nctId': 'NCT04377958', 'briefTitle': 'Development and Validation of a Serum Biomarker for the Diagnostic Work-up of Asthma', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'Development and Validation of a Serum Biomarker for the Diagnostic Work-up of Asthma', 'orgStudyIdInfo': {'id': 's52549'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Asthmatics', 'description': 'Asthmatic group from which serum samples will be collected for analysis', 'interventionNames': ['Diagnostic Test: Serum biomarker testing']}], 'interventions': [{'name': 'Serum biomarker testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Serum and sputum samples will be collected and biomarkers will be evaluated using ELISA', 'armGroupLabels': ['Asthmatics']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Lieven Dupont', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Leuven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tatjana Decaesteker', 'investigatorAffiliation': 'KU Leuven'}}}}