French National Cohort of Children With Port Wine Stain

Port Wine Stain Clinical Trial

— CONAPE  

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01364857
• Other study ID #: PHRN09 - GL / CONAPE
• Status: Completed
• Phase: N/A
• Start date: November 2010
• Est. completion date: November 2019

Study information

• Verified date: August 2023
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Stem Infarctions
• Hemangioma, Capillary
• Klippel Trenaunay Syndrome
• Parkes Weber Syndrome
• Port Wine Stain
• Port-Wine Stain
• Sturge-Weber Syndrome
• Syndrome

Intervention

Genetic:
• 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

Locations

Country	Name	City	State
France	Service de dermatologie	Amiens
France	Service de dermatologie	Angers
France	Service de dermatologie	Bordeaux
France	Service de dermatologie	Caen
France	Service de dermatologie	Dijon
France	Service de Dermatologie, Bâtiment tardieu	Le Mans
France	Service de Dermatologie, Hôpital St Eloi	Montpellier
France	Service de dermatologie	Nantes
France	Service de dermatologie	Nice
France	Service de dermatologie	Paris
France	Service de dermatlogie	Quimper
France	Service de dermatologie	Reims
France	Service de Dermatologie, Hôpital Pontchaillou, CHU de Rennes	Rennes
France	Service de dermatologie	Rouen
France	Service de dermatologie	Saint-Etienne
France	Service de dermatologie	Toulouse
France	Service de dermatologie	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complicated evolution (defined as: vascular, orthopedic or systemic involvement linked with the port wine stain)	Complicated evolution (defined as: vascular, orthopedic or systemic involvement linked with the port wine stain)	during the 5 years of follow up
Secondary	Mutations of RASA 1 gene	Mutations of RASA 1 gene	during the 5 years of follow up