Clinical trial

French National Prospective Cohort of Children With Port Wine Stain on a Limb = "Cohorte Nationale d'Enfants Avec Angiome Plan de Membre inférieur"

Name
PHRN09 - GL / CONAPE
Description
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). Little 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. This 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.
Trial arms
Trial start
2010-11-01
Estimated PCD
2019-11-01
Trial end
2019-11-01
Status
Completed
Treatment
search for polymorphisms of RASA1 gene
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
Arms:
PWS cohort
Size
150
Primary endpoint
Complicated evolution (defined as: vascular, orthopedic or systemic involvement linked with the port wine stain)
during the 5 years of follow up
Eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * child with orthopedic impairment with no link with the port wine stain
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ACTUAL'}}
Updated at
2023-08-16

1 organization

1 product

3 indications

Indication
Port Wine Stain