French National Prospective Cohort of Children With Port Wine Stain on a Limb = "Cohorte Nationale d'Enfants Avec Angiome Plan de Membre inférieur"
2 Years
12 Years
Both
Port Wine Stain, Klippel Trenaunay Syndrome, Parkes Weber Syndrome
Trial Information
French National Prospective Cohort of Children With Port Wine Stain on a Limb = "Cohorte Nationale d'Enfants Avec Angiome Plan de Membre inférieur"
Prospective national study, including 16 Pediatric and Dermatologic Departments.
Methods : each children with a port wine stain on a lower limb will be followed up for 5
years.
Collected 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.
Inclusion period = 3 years Follow up period = 5 years Population = 150 children
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
complicated evolution (defined as: vascular, orthopedic or systemic involvement linked with the port wine stain)
Outcome Time Frame:
during the 5 years of follow up
Safety Issue:
No
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
PHRN09 - GL / CONAPE
NCT ID:
NCT01364857
Start Date:
November 2010
Completion Date:
Related Keywords:
- Port Wine Stain
- Klippel Trenaunay Syndrome
- Parkes Weber Syndrome
- port wine stain of a limb
- Klippel-Trenaunay-Weber Syndrome
- Sturge-Weber Syndrome
- Neurocutaneous Syndromes
- Brain Stem Infarctions
- Port-Wine Stain
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