Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT01619605
Status:
COMPLETED
Last Update Posted:
2012-06-15
First Post:
2012-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Utility of Serum Tryptase in the Diagnosis of Shrimp- Induced Anaphylaxis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D000707', 'term': 'Anaphylaxis'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-14', 'studyFirstSubmitDate': '2012-06-12', 'studyFirstSubmitQcDate': '2012-06-12', 'lastUpdatePostDateStruct': {'date': '2012-06-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Serum tryptases', 'timeFrame': 'baseline and 60 minutes after the onset of symptoms'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['tryptases', 'anaphylaxis', 'shrimp allergy'], 'conditions': ['Food (Shrimp) Allergy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to investigate the utility of serum tryptase for the confirmation of shrimp-induced anaphylaxis.', 'detailedDescription': 'The diagnosis of anaphylaxis is based primarily on the clinical history. In some circumstances, inability to confirm the clinical diagnosis such as present with unusual manifestation, or when skin signs are absent likely contributes to underrecognition and undertreatment of the disease.\n\nCurrently, products of mast cell activation (histamine and total tryptase) can be measure in clinical laboratories as markers of acute anaphylaxis events, however these tests have clinically relevant limitations.\n\nTherefore, development of laboratory tests with improved sensitivity and specificity that will support the clinical diagnosis of anaphylaxis are needed.\n\nIn addition, shrimp is the major cause of seafood anaphylaxis among Thai children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a history of shrimp allergy\n\nExclusion Criteria:\n\n* severe anaphylactic reaction from seafood\n* pregnancy\n* underlying diseases such as cardiovascular, hepatobiliary, and renal diseases\n* on systemic corticosteroid or β-blocking agents'}, 'identificationModule': {'nctId': 'NCT01619605', 'briefTitle': 'The Utility of Serum Tryptase in the Diagnosis of Shrimp- Induced Anaphylaxis', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'The Utility of Serum Tryptase in the Diagnosis of Shrimp- Induced Anaphylaxis', 'orgStudyIdInfo': {'id': '669/2551(EC4)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Shrim', 'interventionNames': ['Procedure: shrimp challenge']}], 'interventions': [{'name': 'shrimp challenge', 'type': 'PROCEDURE', 'otherNames': ['open food challenge'], 'description': 'Patients with history of shrimp allergy and positive skin tests to shrimp were recruited for shrimp challenges After shrimp challenges, patients with anaphylaxis defined as anaphylaxis group, patients with mild reactions defined as mild reaction group, and patients without symptom defined as control group', 'armGroupLabels': ['Shrim']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkoknoi', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Pediatric allergy clinic, Faculty of Medicine Siriraj Hospital, Mahidol University'}], 'overallOfficials': [{'name': 'Orathai Piboonpocanun, Assoc.Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mahidol University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}