Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-29 @ 6:53 PM
Study NCT ID:
NCT01364857
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2011-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
French National Cohort of Children With Port Wine Stain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019339', 'term': 'Port-Wine Stain'}, {'id': 'D007715', 'term': 'Klippel-Trenaunay-Weber Syndrome'}, {'id': 'D013341', 'term': 'Sturge-Weber Syndrome'}], 'ancestors': [{'id': 'D012868', 'term': 'Skin Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D000798', 'term': 'Angiomatosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006391', 'term': 'Hemangioma'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020752', 'term': 'Neurocutaneous Syndromes'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2019-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2011-05-31', 'studyFirstSubmitQcDate': '2011-06-02', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complicated evolution (defined as: vascular, orthopedic or systemic involvement linked with the port wine stain)', 'timeFrame': 'during the 5 years of follow up', 'description': 'Complicated evolution (defined as: vascular, orthopedic or systemic involvement linked with the port wine stain)'}], 'secondaryOutcomes': [{'measure': 'Mutations of RASA 1 gene', 'timeFrame': 'during the 5 years of follow up', 'description': 'Mutations of RASA 1 gene'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['port wine stain of a limb'], 'conditions': ['Port Wine Stain', 'Klippel Trenaunay Syndrome', 'Parkes Weber Syndrome']}, 'referencesModule': {'references': [{'pmid': '29110021', 'type': 'RESULT', 'citation': "Maruani A, Durieux-Verde M, Mazereeuw-Hautier J, Boccara O, Martin L, Chiaverini C, Eschard C, Beneton N, Vabres P, Balguerie X, Plantin P, Bessis D, Barbarot S, Dadban A, Droitcourt C, Berthelot A, Lorette G, Leducq S, Samimi M, Andres C, Caille A, Vourc'h P; Groupe de Recherche de la Societe Francaise de Dermatologie. Search for RASA1 Variants in Capillary Malformations of the Legs in 113 Children: Results from the French National Paediatric Cohort CONAPE. Acta Derm Venereol. 2018 Feb 7;98(2):251-255. doi: 10.2340/00015555-2835."}]}, 'descriptionModule': {'briefSummary': 'Port Wine Stain on a limb can be either isolated or associated with complications (venous or orthopedic impairment, arteriovenous malformations), leading sometimes to complex syndromes (Klippel-Trenaunay syndrome,Parkes-Weber syndrome).\n\nLittle is known about epidemiology of port wine stains: their evolution during the growth of the child, the frequency of complications, genetic data, and prognostic factors.\n\nThis prospective french national cohort will help for : description of the evolution of port wine stain and possible complications; prognostic factors for complications ; association with mutations of RASA1 gene; quality of life of these children. It will also help for global appreciation of the management of this disease in France.', 'detailedDescription': 'Prospective national study, including 16 Pediatric and Dermatologic Departments.\n\nMethods : each children with a port wine stain on a lower limb will be followed up for 5 years.\n\nCollected data : demographic data, clinical features, alterations of RASA1 gene, vascular evaluation by ultrasonographic and orthopedic evaluation by X rays, quality of life with a questionnaire.\n\nInclusion period = 3 years Follow up period = 5 years Population = 150 children'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child between 2 and 12 years old with a port wine stain on a lower limb ( or two lower limbs) with national health assurance with consent from one parent\n\nExclusion Criteria:\n\n* child with orthopedic impairment with no link with the port wine stain'}, 'identificationModule': {'nctId': 'NCT01364857', 'acronym': 'CONAPE', 'briefTitle': 'French National Cohort of Children With Port Wine Stain', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': 'French National Prospective Cohort of Children With Port Wine Stain on a Limb = "Cohorte Nationale d\'Enfants Avec Angiome Plan de Membre inférieur"', 'orgStudyIdInfo': {'id': 'PHRN09 - GL / CONAPE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'PWS cohort', 'description': 'search for polymorphisms of RASA1 gene', 'interventionNames': ['Genetic: search for polymorphisms of RASA1 gene']}], 'interventions': [{'name': 'search for polymorphisms of RASA1 gene', 'type': 'GENETIC', 'description': 'Blood sample ( 5 mL) at tne inclusion of the child DNA extraction and genetic analysis of the 24 exons of RASA1 gene after specific consent', 'armGroupLabels': ['PWS cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'Service de dermatologie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': 'Service de dermatologie', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Service de dermatologie', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': 'Service de dermatologie', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'Service de dermatologie', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '72037', 'city': 'Le Mans', 'country': 'France', 'facility': 'Service de Dermatologie, Bâtiment tardieu', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Service de Dermatologie, Hôpital St Eloi', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Service de dermatologie', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '06202', 'city': 'Nice', 'country': 'France', 'facility': 'Service de dermatologie', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75743', 'city': 'Paris', 'country': 'France', 'facility': 'Service de dermatologie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '29107', 'city': 'Quimper', 'country': 'France', 'facility': 'Service de dermatlogie', 'geoPoint': {'lat': 47.99597, 'lon': -4.09795}}, {'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': 'Service de dermatologie', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'Service de Dermatologie, Hôpital Pontchaillou, CHU de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '76031', 'city': 'Rouen', 'country': 'France', 'facility': 'Service de dermatologie', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Service de dermatologie', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Service de dermatologie', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'Service de dermatologie', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Violaine MIZZI', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Tours'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}