French National Cohort of Children With Port Wine Stain

NCT ID: NCT01364857

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2019-11-30

Brief Summary

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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

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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

Conditions

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Port Wine Stain Klippel Trenaunay Syndrome Parkes Weber Syndrome

Keywords

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port wine stain of a limb

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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PWS cohort

search for polymorphisms of RASA1 gene

Group Type OTHER

search for polymorphisms of RASA1 gene

Intervention Type GENETIC

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

Interventions

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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

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Violaine MIZZI

Role: STUDY_CHAIR

University Hospital, Tours

Locations

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Service de dermatologie

Amiens, , France

Site Status

Service de dermatologie

Angers, , France

Site Status

Service de dermatologie

Bordeaux, , France

Site Status

Service de dermatologie

Caen, , France

Site Status

Service de dermatologie

Dijon, , France

Site Status

Service de Dermatologie, Bâtiment tardieu

Le Mans, , France

Site Status

Service de Dermatologie, Hôpital St Eloi

Montpellier, , France

Site Status

Service de dermatologie

Nantes, , France

Site Status

Service de dermatologie

Nice, , France

Site Status

Service de dermatologie

Paris, , France

Site Status

Service de dermatlogie

Quimper, , France

Site Status

Service de dermatologie

Reims, , France

Site Status

Service de Dermatologie, Hôpital Pontchaillou, CHU de Rennes

Rennes, , France

Site Status

Service de dermatologie

Rouen, , France

Site Status

Service de dermatologie

Saint-Etienne, , France

Site Status

Service de dermatologie

Toulouse, , France

Site Status

Service de dermatologie

Tours, , France

Site Status

Countries

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France

References

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Maruani A, Durieux-Verde M, Mazereeuw-Hautier J, Boccara O, Martin L, Chiaverini C, Eschard C, Beneton N, Vabres P, Balguerie X, Plantin P, Bessis D, Barbarot S, Dadban A, Droitcourt C, Berthelot A, Lorette G, Leducq S, Samimi M, Andres C, Caille A, Vourc'h P; Groupe de Recherche de la Societe Francaise de Dermatologie. Search for RASA1 Variants in Capillary Malformations of the Legs in 113 Children: Results from the French National Paediatric Cohort CONAPE. Acta Derm Venereol. 2018 Feb 7;98(2):251-255. doi: 10.2340/00015555-2835.

Reference Type RESULT
PMID: 29110021 (View on PubMed)

Other Identifiers

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PHRN09 - GL / CONAPE

Identifier Type: -

Identifier Source: org_study_id