Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-02-24 @ 2:06 PM
Study NCT ID:
NCT02535793
Status:
COMPLETED
Last Update Posted:
2016-04-12
First Post:
2015-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterisation of Occupational Allergy to Drosophila
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-11', 'studyFirstSubmitDate': '2015-08-20', 'studyFirstSubmitQcDate': '2015-08-26', 'lastUpdatePostDateStruct': {'date': '2016-04-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with positive prick test to drosophila', 'timeFrame': 'The day of inclusion', 'description': 'Prick tests : measuring the size of the skin reaction (wheal) after prick tests with drosophila. A wheal measuring more than 4 millimeters in diameter sign a sensitization to drosophila. Then, a blood sample is collected in order to measure specific drosophila IgE rate'}], 'secondaryOutcomes': [{'measure': 'Survey to analyse risk factors for allergy to drosophila', 'timeFrame': 'The day of inclusion', 'description': 'analysis of professional (attended institute, time from start working with drosophila, type of animal manipulation (species, living, dead, DNA, protein) use of protection,) or personal factors (age, gender, others allergies, treatment used) which could lead to allergic reaction to drosophila'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Drosophila', 'Clinical Symptoms']}, 'descriptionModule': {'briefSummary': 'Allergy is a very common problem and can be a handicap in everyday life, specially when symptoms occur at work place. Some persons working with drosophila developed respiratory symptoms. Investigators tried to analyze if these manifestations could be due to a specific allergy to drosophila.', 'detailedDescription': 'To do so, investigators invited laboratory workers who presented any symptoms in presence of drosophila to undergo skin prick tests in order to determine if a specific sensibilization to drosophila exists. Then, a blood sample is taken from these persons to research specific IgE directed against drosophila. By this way, investigators hope determine if a specific allergy to drosophila exists, its characteristics as prevalence, symptoms, populations concerned...in order to better protect laboratory workers and prevent allergy incidence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '68 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* major males or females (aged \\<68) who work in laboratory with drosophila in Montpellier (France)\n* clinical symptoms in presence of drosophila\n* The subject must be affiliated to a social security scheme\n* Provision of informed consent prior to any study specific procedures\n\nExclusion Criteria:\n\n* The patient has indicated against (or incompatible drug combination) concerning the implementation of a prick test\n* antihistamine cure in progress\n* Inability to understand the nature and goals of the study and / or communication difficulties with the investigator\n* No affiliation to a French social security recipient or not such a scheme\n* Major protected by law (guardianship, curator or under judicial protection)\n* deprivation of liberty by judicial or administrative decision\n* Increased likelihood of non compliance to the protocol or abandonment under study\n* pregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT02535793', 'acronym': 'DROSOALLERG', 'briefTitle': 'Characterisation of Occupational Allergy to Drosophila', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'orgStudyIdInfo': {'id': 'UF 9410'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'laboratory workers with symptoms in presence of drosophila', 'interventionNames': ['Other: blood test (four dry tubes 7ml) and prick tests']}], 'interventions': [{'name': 'blood test (four dry tubes 7ml) and prick tests', 'type': 'OTHER', 'armGroupLabels': ['laboratory workers with symptoms in presence of drosophila']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Hôpital Arnaud de Villeneuve', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}