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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01364857
Recruitment Status : Unknown
Verified February 2017 by University Hospital, Tours.
Recruitment status was:  Active, not recruiting
First Posted : June 3, 2011
Last Update Posted : February 24, 2017
Information provided by (Responsible Party):
University Hospital, Tours

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.

Condition or disease Intervention/treatment Phase
Port Wine Stain Klippel Trenaunay Syndrome Parkes Weber Syndrome Genetic: search for polymorphisms of RASA1 gene Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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"
Actual Study Start Date : November 2010
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Arm Intervention/treatment
PWS cohort
search for polymorphisms of RASA1 gene
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

Primary Outcome Measures :
  1. complicated evolution (defined as: vascular, orthopedic or systemic involvement linked with the port wine stain) [ Time Frame: during the 5 years of follow up ]

Secondary Outcome Measures :
  1. mutations of RASA 1 gene [ Time Frame: during the 5 years of follow up ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01364857

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Service de dermatologie
Amiens, France, 80054
Service de dermatologie
Angers, France, 49933
Service de dermatologie
Bordeaux, France, 33000
Service de dermatologie
Caen, France, 14033
Service de dermatologie
Dijon, France, 21079
Service de Dermatologie, Bâtiment tardieu
Le Mans, France, 72037
Service de Dermatologie, Hôpital St Eloi
Montpellier, France, 34295
Service de dermatologie
Nantes, France, 44093
Service de dermatologie
Nice, France, 06202
Service de dermatologie
Paris, France, 75743
Service de dermatlogie
Quimper, France, 29107
Service de dermatologie
Reims, France, 51092
Service de Dermatologie, Hôpital Pontchaillou, CHU de Rennes
Rennes, France, 35033
Service de dermatologie
Rouen, France, 76031
Service de dermatologie
Saint-Etienne, France, 42055
Service de dermatologie
Toulouse, France, 31059
Service de dermatologie
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Tours
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Study Chair: Violaine MIZZI University Hospital, Tours
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Responsible Party: University Hospital, Tours Identifier: NCT01364857    
Other Study ID Numbers: PHRN09 - GL / CONAPE
First Posted: June 3, 2011    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017
Keywords provided by University Hospital, Tours:
port wine stain of a limb
Additional relevant MeSH terms:
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Hemangioma, Capillary
Sturge-Weber Syndrome
Brain Stem Infarctions
Klippel-Trenaunay-Weber Syndrome
Port-Wine Stain
Pathologic Processes
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurocutaneous Syndromes
GTPase-Activating Proteins
GTP Phosphohydrolase Activators
Enzyme Activators
Molecular Mechanisms of Pharmacological Action