French National Cohort of Children With Port Wine Stain (CONAPE)

This study is currently recruiting participants.
Verified November 2013 by University Hospital, Tours
Sponsor:
Information provided by:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT01364857
First received: May 31, 2011
Last updated: November 8, 2013
Last verified: November 2013

May 31, 2011
November 8, 2013
November 2010
November 2019   (final data collection date for primary outcome measure)
complicated evolution (defined as: vascular, orthopedic or systemic involvement linked with the port wine stain) [ Time Frame: during the 5 years of follow up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01364857 on ClinicalTrials.gov Archive Site
mutations of RASA 1 gene [ Time Frame: during the 5 years of follow up ] [ Designated as safety issue: No ]
mutations of RASA 1 gene [ Designated as safety issue: No ]
Not Provided
Not Provided
 
French National Cohort of Children With Port Wine Stain
French National Prospective Cohort of Children With Port Wine Stain on a Limb = "Cohorte Nationale d'Enfants Avec Angiome Plan de Membre inférieur"

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.

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

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Port Wine Stain
  • Klippel Trenaunay Syndrome
  • Parkes Weber Syndrome
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
Not Provided
November 2019   (final data collection date for primary outcome measure)

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
Both
2 Years to 12 Years
No
Contact: Gérard LORETTE, Pr (33) 02 47 47 86 42 lorette@med.univ-tours.fr
Contact: Aurélie AVARGUES (33) 02 47 47 46 38 aurelie.avargues@med.univ-tours.fr
France
 
NCT01364857
PHRN09 - GL / CONAPE
No
University Hospital, Tours
University Hospital, Tours
Not Provided
Not Provided
University Hospital, Tours
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP