Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-03-26 @ 7:44 PM
Study NCT ID:
NCT00822250
Status:
COMPLETED
Last Update Posted:
2010-10-21
First Post:
2009-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Biological Study of Sub-pigmentation During Infantile Cystinosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003554', 'term': 'Cystinosis'}], 'ancestors': [{'id': 'D016464', 'term': 'Lysosomal Storage Diseases'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-20', 'studyFirstSubmitDate': '2009-01-13', 'studyFirstSubmitQcDate': '2009-01-13', 'lastUpdatePostDateStruct': {'date': '2010-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to determine molecular mechanism of the disease', 'timeFrame': 'at time= 0'}], 'secondaryOutcomes': [{'measure': 'to research relationship between skin phenotype and cystinosis', 'timeFrame': 'at time =0'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cystinosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the molecular mechanism of this disease and to research the relationship between cystinosis and skin phenotype.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. cystinosis\n2. known CTNS mutation\n\nExclusion Criteria:\n\n1. patient with corticotherapy treatment\n2. patient with immunosuppressant treatment'}, 'identificationModule': {'nctId': 'NCT00822250', 'briefTitle': 'Clinical and Biological Study of Sub-pigmentation During Infantile Cystinosis', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Clinical and Biological Study of Sub-pigmentation During Infantile Cystinosis', 'orgStudyIdInfo': {'id': '07-PP-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'cutting hair, skin phenotype description', 'interventionNames': ['Other: analysis of pigmentation']}], 'interventions': [{'name': 'analysis of pigmentation', 'type': 'OTHER', 'otherNames': ['surgical biopsy', 'skin examination'], 'description': 'cutting hair, skin description, skin biopsy for only 4 patients', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'country': 'France', 'facility': 'department of dermatology, Nice University Hospital', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': "Département de la Recherche Clinique et de l'Innovation", 'oldOrganization': 'CHU de Nice'}}}}