Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-31 @ 9:10 PM
Study NCT ID:
NCT05826405
Status:
UNKNOWN
Last Update Posted:
2023-04-24
First Post:
2023-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Oral Cashew Nut Immunotherapy in Children (CAJESITO)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005512', 'term': 'Food Hypersensitivity'}, {'id': 'D021184', 'term': 'Nut Hypersensitivity'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D000074924', 'term': 'Nut and Peanut Hypersensitivity'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-05-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-21', 'studyFirstSubmitDate': '2023-04-07', 'studyFirstSubmitQcDate': '2023-04-21', 'lastUpdatePostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of allergic reaction', 'timeFrame': 'during 6 months'}], 'secondaryOutcomes': [{'measure': 'Predictive factor of good tolerance', 'timeFrame': 'during 6 months', 'description': 'age at onset'}, {'measure': 'antibody variation', 'timeFrame': 'during 6 months', 'description': 'Modification of level of specific IgE and IGg4 with cashew nuts'}, {'measure': 'sustained unresponsiveness', 'timeFrame': '9 months', 'description': 'Tolerance of 1, 2, 4, 8g in isolated doses and 15g in total cumulative dose of cashew nuts during an oral challenge test with cashew nuts 3 months after stopping the daily consumption of 2g of cashew nuts'}, {'measure': 'oral tolerance of pistachio', 'timeFrame': '6 months', 'description': 'Tolerance of 1, 2, 4, 8g in isolated doses and 15g in total cumulative dose of pistachio during an oral provocation test with pistachio 3 months after stopping the daily consumption of 2g of cashew nuts'}, {'measure': 'Predictive factor of good tolerance', 'timeFrame': '6 months', 'description': 'antecedent of severe allergic reaction'}, {'measure': 'Predictive factor of good tolerance', 'timeFrame': '6 months', 'description': 'initial reactogenic threshold'}, {'measure': 'Predictive factor of good tolerance', 'timeFrame': '6 months', 'description': 'presence atopy (asthma, food allergy or atopic dermatitis)'}, {'measure': 'Predictive factor of good tolerance', 'timeFrame': '6 months', 'description': 'initial specific IgE and Ana o3 levels'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['allergy', 'food allergy', 'cashew nut allergy', 'oral immunotherapy', 'pistachio allergy'], 'conditions': ['Allergy;Food', 'Allergy, Nut']}, 'descriptionModule': {'briefSummary': 'The objectives of the CAJESITO study are (i) to assess the tolerance of oral cashew nut immunotherapy, by describing the frequency and severity of allergic reactions during oral cashew nut immunotherapy and (ii )to assess the risk factors for severe allergic reactions during oral cashew nut immunotherapy (predictive factors, associated factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients from 0 to 18 years old followed in allergology at the University Hospital of Nancy benefiting from oral immunotherapy with cashew nuts for at least 18 months as of 02/28/2023', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients under the age of 18 with a proven allergy to cashew nuts and followed in the pediatric allergology unit of the University Hospital of Nancy.\n* Patients who have received oral cashew nut immunotherapy for at least 18 months as of 02/28/2023\n\nExclusion Criteria:\n\n* Patients who have received oral cashew nut immunotherapy for less than 18 months.\n* Patients lost to follow-up for more than 3 years, i.e. last consultation dating from 2020 or earlier'}, 'identificationModule': {'nctId': 'NCT05826405', 'acronym': 'CAJESITO', 'briefTitle': 'Efficacy and Safety of Oral Cashew Nut Immunotherapy in Children (CAJESITO)', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Efficacy and Safety of Oral Cashew Nut Immunotherapy in Children (CAJESITO)', 'orgStudyIdInfo': {'id': 'FORM-03935'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cashew Nut allergic', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': "No intervention, it's an observational study", 'armGroupLabels': ['Cashew Nut allergic']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Amandine AD DIVARET-CHAUVEAU, MCU PH', 'role': 'CONTACT', 'email': 'a.chauveau@chru-nancy.fr', 'phone': '+3383153695'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Amandine DIVARET-CHAUVEAU', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}