Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-04 @ 7:56 AM
Study NCT ID:
NCT04407104
Status:
UNKNOWN
Last Update Posted:
2020-07-21
First Post:
2020-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Allergy to Almond in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010328', 'term': 'Patch Tests'}], 'ancestors': [{'id': 'D012882', 'term': 'Skin Tests'}, {'id': 'D007159', 'term': 'Immunologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-07-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-09-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-20', 'studyFirstSubmitDate': '2020-05-25', 'studyFirstSubmitQcDate': '2020-05-25', 'lastUpdatePostDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'diagnostic values of skin prick-test and sIgE to almond', 'timeFrame': 'BASELINE'}], 'secondaryOutcomes': [{'measure': 'allergic reactions during oral food challenge', 'timeFrame': 'BASELINE', 'description': 'symptoms and severity'}, {'measure': 'eliciting doses to almond', 'timeFrame': 'BASELINE', 'description': 'ED05, ED10 and ED50'}, {'measure': 'atopic comorbidities', 'timeFrame': 'BASELINE', 'description': 'respiratory allergies, other food allergies, asthma'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['almond', 'tree nuts', 'atopy', 'allergy', 'children'], 'conditions': ['Food Allergy in Children']}, 'descriptionModule': {'briefSummary': 'Allergy to tree nuts are frequent in children but allergy to almond is one of the less described tree nuts allergy. The main objective of our study is to determine diagnostic values of skin prick-tests and specific IgE to almond in a population of children sensitized to almond and challenged in our unit from november 2013 to march 2020.', 'detailedDescription': 'Secondary objectives are\n\n* description of allergic reactions to almond (symptoms, severity)\n* modelisation of eliciting dose to almond in our population\n* evaluation of the association between atopic comorbidities and allergy to almond in children sensitized to almond\n* evaluation of the association between allergy to almond and the importance of skin and sIgE sensitization'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'children sensitized to almond and challenged in our unit', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* oral food challenge to almond performed in the pediatric allergy department of the University Hospital of Nancy from november 2013 and march 2020\n\nExclusion Criteria:\n\n* doubtful or incomplete oral food challenge to almond'}, 'identificationModule': {'nctId': 'NCT04407104', 'briefTitle': 'Allergy to Almond in Children', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Allergy to Almond in Children: Diagnostic Values and Severity', 'orgStudyIdInfo': {'id': '2020PI100'}}, 'armsInterventionsModule': {'interventions': [{'name': 'skin prick-test', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['specific IgE', 'oral food challenge'], 'description': 'retrospective study on data already collected'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}