Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-03-02 @ 4:11 AM
Study NCT ID:
NCT05807958
Status:
COMPLETED
Last Update Posted:
2025-02-28
First Post:
2023-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Allergy Testing of Soldiers Prepared for International Mission
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-26', 'studyFirstSubmitDate': '2023-03-14', 'studyFirstSubmitQcDate': '2023-03-28', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Allergens with positive skin reaction', 'timeFrame': 'baseline', 'description': 'Positive skin reactions of top ranked allergens required to identify 95% of sensitised individuals'}], 'secondaryOutcomes': [{'measure': 'Self-reported allergic diseases', 'timeFrame': 'baseline', 'description': 'Percentage of soldiers with self-reported allergic diseases derived from questionnaire'}, {'measure': 'Work Performance & Activity Impairment', 'timeFrame': 'baseline', 'description': 'Total score of Work Performance \\& Activity Impairment questionnaire, 0-100%, higher score means worse outcome'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adult Military Personnel']}, 'referencesModule': {'references': [{'pmid': '36495473', 'type': 'BACKGROUND', 'citation': 'Gorris S, Uyttebroek S, Backaert W, Jorissen M, Schrijvers R, Thompson MJ, Loeckx D, Seys SF, Van Gerven L, Hellings PW. Reduced intra-subject variability of an automated skin prick test device compared to a manual test. Allergy. 2023 May;78(5):1366-1368. doi: 10.1111/all.15619. Epub 2022 Dec 26. No abstract available.'}, {'pmid': '40562451', 'type': 'DERIVED', 'citation': 'Gorris S, Baron I, De Brouwer J, Vanden Daele A, Verstraelen J, Loeckx D, Bousquet J, Van Gerven L, Seys SF. Sensitisation patterns and burden of uncontrolled respiratory allergy symptoms in military personnel. BMJ Mil Health. 2025 Jun 25:military-2025-003006. doi: 10.1136/military-2025-003006. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this prospective mono centric study is to identify relevant commercially available allergen extracts for allergy testing in soldiers prepared for international mission.\n\nParticipants will receive a skin prick test with the skin prick automated test device including 22 allergens and 2 controls on both forearms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult military personnel (18-65y) will be included. Soldiers with and without previous exposure to allergens in the regions of interest will be included. Soldiers who are performing desk tasks and not selected for international missions will serve as controls.\n\nExclusion Criteria:\n\n* Skin pathology like chronic or exuberant urticaria, dermographism, chronic dermatitis that needs daily treatment\n* Use of antihistaminic medication \\< 7 days before the start of the study\n* Use of tricyclic antidepressants (antihistamine activity) \\< 7 days before the start of the study\n* Use of topical corticoids on the forearm \\< 7 days before the start of the study\n* Use of Omalizumab \\< 6 months before the start of the study\n* Pregnancy: there is a remote possibility of inducing a systemic allergic reaction that could induce uterine contractions or necessitate the use of epinephrine (thought to cause constriction of the umbilical artery).'}, 'identificationModule': {'nctId': 'NCT05807958', 'acronym': 'SPAT_ABL', 'briefTitle': 'Allergy Testing of Soldiers Prepared for International Mission', 'organization': {'class': 'OTHER', 'fullName': 'Queen Astrid Military Hospital'}, 'officialTitle': 'Validation of the Benefit of Allergy Testing of Soldiers Prepared for International Mission with Specific Allergen Panels', 'orgStudyIdInfo': {'id': '22467'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Skin Prick Automated Test', 'interventionNames': ['Device: Skin Prick Automated Test']}], 'interventions': [{'name': 'Skin Prick Automated Test', 'type': 'DEVICE', 'description': 'A skin prick automated test will be performed in each participant.', 'armGroupLabels': ['Skin Prick Automated Test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1120', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Military Hospital Queen Astrid', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Ilan Baron, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Military Hospital Queen Astrid'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Astrid Military Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor', 'investigatorFullName': 'Ilan Baron', 'investigatorAffiliation': 'Queen Astrid Military Hospital'}}}}