Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
University Hospital, Tours Identifier:
First received: May 31, 2011
Last updated: February 23, 2017
Last verified: February 2017

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 Intervention
Port Wine Stain
Klippel Trenaunay Syndrome
Parkes Weber Syndrome
Genetic: search for polymorphisms of RASA1 gene

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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"

Resource links provided by NLM:

Further study details as provided by University Hospital, Tours:

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

Estimated Enrollment: 150
Actual Study Start Date: November 2010
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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


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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01364857

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
Study Chair: Violaine MIZZI University Hospital, Tours
  More Information

Responsible Party: University Hospital, Tours Identifier: NCT01364857     History of Changes
Other Study ID Numbers: PHRN09 - GL / CONAPE
Study First Received: May 31, 2011
Last Updated: February 23, 2017

Keywords provided by University Hospital, Tours:
port wine stain of a limb

Additional relevant MeSH terms:
Klippel-Trenaunay-Weber Syndrome
Sturge-Weber Syndrome
Port-Wine Stain
Hemangioma, Capillary
Vascular Malformations
Brain Stem Infarctions
Pathologic Processes
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Cardiovascular Abnormalities
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Neurocutaneous Syndromes
GTPase-Activating Proteins
GTP Phosphohydrolase Activators processed this record on April 26, 2017