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

Primary Purpose

Port Wine Stain, Klippel Trenaunay Syndrome, Parkes Weber Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
search for polymorphisms of RASA1 gene
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Port Wine Stain focused on measuring port wine stain of a limb

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service de dermatologie
  • Service de dermatologie
  • Service de dermatologie
  • Service de dermatologie
  • Service de dermatologie
  • Service de Dermatologie, Bâtiment tardieu
  • Service de Dermatologie, Hôpital St Eloi
  • Service de dermatologie
  • Service de dermatologie
  • Service de dermatologie
  • Service de dermatlogie
  • Service de dermatologie
  • Service de Dermatologie, Hôpital Pontchaillou, CHU de Rennes
  • Service de dermatologie
  • Service de dermatologie
  • Service de dermatologie
  • Service de dermatologie

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

PWS cohort

Arm Description

search for polymorphisms of RASA1 gene

Outcomes

Primary Outcome Measures

Complicated evolution (defined as: vascular, orthopedic or systemic involvement linked with the port wine stain)
Complicated evolution (defined as: vascular, orthopedic or systemic involvement linked with the port wine stain)

Secondary Outcome Measures

Mutations of RASA 1 gene
Mutations of RASA 1 gene

Full Information

First Posted
May 31, 2011
Last Updated
August 11, 2023
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT01364857
Brief Title
French National Cohort of Children With Port Wine Stain
Acronym
CONAPE
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"
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 2010 (Actual)
Primary Completion Date
November 2019 (Actual)
Study Completion Date
November 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Port Wine Stain, Klippel Trenaunay Syndrome, Parkes Weber Syndrome
Keywords
port wine stain of a limb

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PWS cohort
Arm Type
Other
Arm Description
search for polymorphisms of RASA1 gene
Intervention Type
Genetic
Intervention Name(s)
search for polymorphisms of RASA1 gene
Intervention Description
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 Measure Information:
Title
Complicated evolution (defined as: vascular, orthopedic or systemic involvement linked with the port wine stain)
Description
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 Measure Information:
Title
Mutations of RASA 1 gene
Description
Mutations of RASA 1 gene
Time Frame
during the 5 years of follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Violaine MIZZI
Organizational Affiliation
University Hospital, Tours
Official's Role
Study Chair
Facility Information:
Facility Name
Service de dermatologie
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Service de dermatologie
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Service de dermatologie
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Service de dermatologie
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Service de dermatologie
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Service de Dermatologie, Bâtiment tardieu
City
Le Mans
ZIP/Postal Code
72037
Country
France
Facility Name
Service de Dermatologie, Hôpital St Eloi
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Service de dermatologie
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Service de dermatologie
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Service de dermatologie
City
Paris
ZIP/Postal Code
75743
Country
France
Facility Name
Service de dermatlogie
City
Quimper
ZIP/Postal Code
29107
Country
France
Facility Name
Service de dermatologie
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Service de Dermatologie, Hôpital Pontchaillou, CHU de Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Service de dermatologie
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Service de dermatologie
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
Service de dermatologie
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Service de dermatologie
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

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French National Cohort of Children With Port Wine Stain

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