Clinical trial NCT01364857: French National Cohort of Children With Port Wine Stain
Official title: French National Prospective Cohort of Children With Port Wine Stain on a Limb = "Cohorte Nationale d'Enfants Avec Angiome Plan de Membre inférieur"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Port Wine Stain
Klippel Trenaunay Syndrome
Parkes Weber Syndrome
Keywords: port wine stain of a limb
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2011-06-03
Enrollment: 150
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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

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

Primary outcomes:
measure: Complicated evolution (defined as: vascular, orthopedic or systemic involvement linked with the port wine stain)
timeFrame: during the 5 years of follow up
Secondary outcomes:
measure: Mutations of RASA 1 gene
timeFrame: during the 5 years of follow up
Other outcomes:
Locations:
city: Amiens
country: France
facility: Service de dermatologie
city: Angers
country: France
facility: Service de dermatologie
city: Bordeaux
country: France
facility: Service de dermatologie
city: Caen
country: France
facility: Service de dermatologie
city: Dijon
country: France
facility: Service de dermatologie
city: Le Mans
country: France
facility: Service de Dermatologie, Bâtiment tardieu
city: Montpellier
country: France
facility: Service de Dermatologie, Hôpital St Eloi
city: Nantes
country: France
facility: Service de dermatologie
city: Nice
country: France
facility: Service de dermatologie
city: Paris
country: France
facility: Service de dermatologie
city: Quimper
country: France
facility: Service de dermatlogie
city: Reims
country: France
facility: Service de dermatologie
city: Rennes
country: France
facility: Service de Dermatologie, Hôpital Pontchaillou, CHU de Rennes
city: Rouen
country: France
facility: Service de dermatologie
city: Saint-Etienne
country: France
facility: Service de dermatologie
city: Toulouse
country: France
facility: Service de dermatologie
city: Tours
country: France
facility: Service de dermatologie
Study officials:
affiliation: University Hospital, Tours
name: Violaine MIZZI
role: STUDY_CHAIR
References: