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

August 11, 2023 updated by: University Hospital, Tours

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • 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
      • Le Mans, France, 72037
        • Service de Dermatologie, Bâtiment tardieu
      • Montpellier, France, 34295
        • Service de Dermatologie, Hôpital St Eloi
      • Nantes, France, 44093
        • Service de dermatologie
      • Nice, France, 06202
        • Service de dermatologie
      • Paris, France, 75743
        • Service de dermatologie
      • Quimper, France, 29107
        • Service de dermatlogie
      • Reims, France, 51092
        • Service de dermatologie
      • Rennes, France, 35033
        • Service de Dermatologie, Hôpital Pontchaillou, CHU de Rennes
      • Rouen, France, 76031
        • Service de dermatologie
      • Saint-Etienne, France, 42055
        • Service de dermatologie
      • Toulouse, France, 31059
        • Service de dermatologie
      • Tours, France, 37044
        • Service de dermatologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complicated evolution (defined as: vascular, orthopedic or systemic involvement linked with the port wine stain)
Time Frame: during the 5 years of follow up
Complicated evolution (defined as: vascular, orthopedic or systemic involvement linked with the port wine stain)
during the 5 years of follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mutations of RASA 1 gene
Time Frame: during the 5 years of follow up
Mutations of RASA 1 gene
during the 5 years of follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Study Chair: Violaine MIZZI, University Hospital, Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2010

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

May 31, 2011

First Submitted That Met QC Criteria

June 2, 2011

First Posted (Estimated)

June 3, 2011

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 11, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRN09 - GL / CONAPE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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