Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-01-11 @ 9:57 AM
Study NCT ID:
NCT00569361
Status:
COMPLETED
Last Update Posted:
2009-06-09
First Post:
2007-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nasal Epithelium Gene Expression Profiling in Child Respiratory Allergic Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-08', 'studyFirstSubmitDate': '2007-12-06', 'studyFirstSubmitQcDate': '2007-12-06', 'lastUpdatePostDateStruct': {'date': '2009-06-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transcriptome analysis: genes statistically modulated between groups, predictive biomarkers allowing correct classification of groups', 'timeFrame': 'At the sample time'}], 'secondaryOutcomes': [{'measure': 'Validation with other techniques: Q-PCR', 'timeFrame': 'At the sample time'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['allergic rhinitis to dust mite', 'allergic rhinitis associated with bronchial hyperreactivity', 'allergic rhinitis associated with asthma'], 'conditions': ['Allergic Rhinitis']}, 'referencesModule': {'references': [{'pmid': '22005912', 'type': 'DERIVED', 'citation': 'Giovannini-Chami L, Marcet B, Moreilhon C, Chevalier B, Illie MI, Lebrigand K, Robbe-Sermesant K, Bourrier T, Michiels JF, Mari B, Crenesse D, Hofman P, de Blic J, Castillo L, Albertini M, Barbry P. Distinct epithelial gene expression phenotypes in childhood respiratory allergy. Eur Respir J. 2012 May;39(5):1197-205. doi: 10.1183/09031936.00070511. Epub 2011 Oct 17.'}]}, 'descriptionModule': {'briefSummary': 'Using a human pangenomic microarray, the researchers established expression profiles of nasal epithelial cells, collected by brushing of patients belonging to one of four distinct groups:\n\n1. allergic rhinitis to dust mite (AR) isolated (n=12),\n2. AR associated with bronchial hyperreactivity (n=12),\n3. AR associated with asthma (n=14),\n4. control (n=14).', 'detailedDescription': 'Context: Asthma is the most frequent chronic disease in childhood. Allergic rhinitis has been described as a risk factor to develop asthma. The objective of the study was to evaluate the contribution of the respiratory epithelium to development of allergic rhinitis and asthma and to identify the molecular mechanisms driving rhinitis toward asthma.\n\nMethods: Using a human pangenomic microarray, we established expression profiles of nasal epithelial cells, collected by brushing of patients belonging to one of four distinct children 2 to 18 years of age groups:\n\n1. allergic rhinitis to dust mite (AR) isolated (n=12),\n2. AR associated with bronchial hyperreactivity (n=12),\n3. AR associated with asthma (n=14),\n4. control (n=14).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients:\n\n* Patients between 6 and 17 years old\n* Patients with allergic rhinitis\n\nWitness:\n\n* Patients between 6 and 17 years old\n* Patients without allergic rhinitis and asthma\n\nExclusion Criteria:\n\n* Rhino-bronchitis infection dated from less than 15 days\n* Patients younger than 6 or older than 17 years'}, 'identificationModule': {'nctId': 'NCT00569361', 'briefTitle': 'Nasal Epithelium Gene Expression Profiling in Child Respiratory Allergic Disease', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Nasal Epithelium Gene Expression Profiling in Child Respiratory Allergic', 'orgStudyIdInfo': {'id': 'CIR 2005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'A', 'description': 'Collection of nasal epithelial cells by brushing', 'interventionNames': ['Procedure: Collection of nasal epithelial cells']}], 'interventions': [{'name': 'Collection of nasal epithelial cells', 'type': 'PROCEDURE', 'description': 'Collection of nasal epithelial cells by brushing', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'country': 'France', 'facility': 'Department of Pediatrics, Nice University Hospital', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'Marc Albertini, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Pediatrics of Nice University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'collaborators': [{'name': 'ADPHUN, FRM', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': "Département de la Recherche Clinique et de l'Innovation", 'oldOrganization': 'CHU de Nice'}}}}