Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:45 AM
Study NCT ID:
NCT00805402
Status:
COMPLETED
Last Update Posted:
2025-07-16
First Post:
2008-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Interest of Flow Cytometry for the Diagnosis, the Follow up and Specific Immunotherapy (SIT) Arrest of Hymenoptera Venom Allergy
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': 'D005434', 'term': 'Flow Cytometry'}], 'ancestors': [{'id': 'D002469', 'term': 'Cell Separation'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003592', 'term': 'Cytophotometry'}, {'id': 'D005470', 'term': 'Fluorometry'}, {'id': 'D008163', 'term': 'Luminescent Measurements'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-13', 'studyFirstSubmitDate': '2008-12-02', 'studyFirstSubmitQcDate': '2008-12-08', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '% CD63 expression on basophil membrane by flow Cytometry', 'timeFrame': 'Inclusion , Week 1, Week 3, Week 10 and Week 21 visits'}], 'secondaryOutcomes': [{'measure': 'Blood blocking factors level', 'timeFrame': 'Week 1, Week 3, Week 10 and Week 21 visits'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Allergy']}, 'referencesModule': {'references': [{'pmid': '27685197', 'type': 'BACKGROUND', 'citation': 'Sainte-Laudy J, Touraine F, Cluzan D, Belle Moudourou F. Follow-Up of Venom Immunotherapy on Flow Cytometry and Definition of a Protective Index. Int Arch Allergy Immunol. 2016;170(4):243-250. doi: 10.1159/000449162. Epub 2016 Sep 30.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to show that flow cytometry can be an accurate tool to help physicians regarding the diagnosis, the SIT decision and the SIT arrest of hymenoptera venom allergy.\n\n75 patients having a story of reaction to hymenoptera venom will be selected for this trial.\n\nBlood samples will be analyzed at: inclusion visit, Week 1 visit, Week 3 visit, Week 10 and Week 21 visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient (18 - 70 years)\n* Patient being informed and accepting to participate in the study with signature of informed consent\n* Patients having a clinical systematic and local, loco-regional story of reaction to the piqures of hymenopterans.\n* Patients treated by SIT for at least 5 years\n* Patients benefiting from a national insurance health\n\nExclusion Criteria:\n\n* Children\n* Pregnant woman or who breast-feed\n* Patient under antihistaminic or corticoid for less than 8 days before the blood drawing\n* Protected Patient\n* Patient not having given his agreement after it was informed'}, 'identificationModule': {'nctId': 'NCT00805402', 'acronym': 'Cytoven', 'briefTitle': 'Interest of Flow Cytometry for the Diagnosis, the Follow up and Specific Immunotherapy (SIT) Arrest of Hymenoptera Venom Allergy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Limoges'}, 'officialTitle': 'Interest of Flow Cytometry for the Diagnosis, the Follow up and SIT Arrest of Hymenoptera Venom Allergy', 'orgStudyIdInfo': {'id': 'I07021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 flow cytometry', 'description': 'flow cytometry', 'interventionNames': ['Other: flow cytometry']}], 'interventions': [{'name': 'flow cytometry', 'type': 'OTHER', 'description': 'flow cytometry', 'armGroupLabels': ['1 flow cytometry']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87000', 'city': 'Limoges', 'country': 'France', 'facility': 'Service Pathologie Respiratoire', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}], 'overallOfficials': [{'name': 'Michel COGNE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Limoges'}, {'name': 'Jean Sainte-Laudy, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU Limoges'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Limoges', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}