Trial record 8 of 12 for:    Sturge-Weber Syndrome

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University Hospital, Tours
Sponsor:
Information provided by:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT01364857
First received: May 31, 2011
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

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: 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"

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mutations of RASA 1 gene [ Time Frame: during the 5 years of follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: November 2010
Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)
Intervention Details:
    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

  Eligibility

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT01364857

Contacts
Contact: Gérard LORETTE, Pr (33) 02 47 47 86 42 lorette@med.univ-tours.fr
Contact: Aurélie AVARGUES (33) 02 47 47 46 38 aurelie.avargues@med.univ-tours.fr

Locations
France
Service de dermatologie Recruiting
Amiens, France, 80054
Contact: Catherine LOK, Pr       lok.catherine@chu-amiens.fr   
Contact: Aurélie Avargues       aurelie.avargues@med.chu-tours.fr   
Principal Investigator: Catherine LOK, Pr         
Service de dermatologie Recruiting
Angers, France, 49933
Contact: Ludovic Martin, Dr       LuMartin@chu-angers.fr   
Contact: Aurélie Avargues       aurelie.avargues@med.chu-tours.fr   
Principal Investigator: Ludovic Martin, Dr         
Service de dermatologie Active, not recruiting
Bordeaux, France, 33000
Service de dermatologie Active, not recruiting
Caen, France, 14033
Service de dermatologie Recruiting
Dijon, France, 21079
Contact: Pierre Vabres, Pr       pierre.vabres@chu-dijon.fr   
Contact: Aurélie Avargues       aurelie.avargues@med.chu-tours.fr   
Principal Investigator: Pierre Vabres, Pr         
Service de Dermatologie, Bâtiment tardieu Recruiting
Le Mans, France, 72037
Contact: Nathalie BENETON-BENHARD, PH    +33243432484    nbeneton@ch-lemans.fr   
Contact: Aurélie AVARGUES    +33247474638    aurelie.avargues@med.univ-tours.fr   
Principal Investigator: Nathalie BENETON-BENHARD         
Service de Dermatologie, Hôpital St Eloi Recruiting
Montpellier, France, 34295
Contact: Didier BESSIS, PH    +334 67 33 69 06    d-bessis@chu-montpellier.fr   
Contact: Aurélie AVARGUES    +33247474638    aurelie.avargues@med.univ-tours.fr   
Principal Investigator: Didier BESSIS         
Service de dermatologie Recruiting
Nantes, France, 44093
Contact: Sébastien BARBAROT, Dr       sebastien.barbarot@chu-nantes.fr   
Contact: Aurélie AVARGUES       aurelie.avargues@med.chu-tours.fr   
Principal Investigator: Sébastien BARBAROT, Dr         
Service de dermatologie Recruiting
Nice, France, 06202
Contact: Jean-Philippe Lacour, Pr       lacour.jp@chu-nice.fr   
Contact: Aurélie Avargues       aurelie.avargues@med.chu-tours.fr   
Principal Investigator: Jean-Philippe Lacour, Pr         
Service de dermatologie Recruiting
Paris, France, 75743
Contact: Olivia Boccara, Dr       olivia.boccara@nck.aphp.fr   
Contact: Aurélie AVARGUES       aurelie.avargues@med.chu-tours.fr   
Principal Investigator: Olivia Boccara, Dr         
Service de dermatlogie Recruiting
Quimper, France, 29107
Contact: Patrice PLANTIN, Dr       p.plantin@ch-cornouaille.fr   
Contact: Aurélie Avargues       aurelie.avargues@med.chu-tours.fr   
Principal Investigator: Patrice Plantin, Dr         
Service de dermatologie Recruiting
Reims, France, 51092
Contact: catherine ESCHARD, dr       ceschard@chu-reims.fr   
Contact: Aurélie AVARGUES       aurelie.avargues@med.chu-tours.fr   
Principal Investigator: Catherine Eschard, Dr         
Service de Dermatologie, Hôpital Pontchaillou, CHU de Rennes Not yet recruiting
Rennes, France, 35033
Contact: Catherine DROITCOURT    +332 99 28 43 49    Catherine.DROITCOURT@chu-rennes.fr   
Contact: Aurélie AVARGUES    +33247474638    aurelie.avargues@med.univ-tours.fr   
Principal Investigator: Catherine DROITCOURT         
Service de dermatologie Recruiting
Rouen, France, 76031
Contact: Xavier BALGUERIE, Dr       Xavier.Balguerie@chu-rouen.fr   
Contact: Aurélie AVARGUES       aurelie.avargues@med.univ-tours.fr   
Principal Investigator: Xavier BALGUERIE, Dr         
Service de dermatologie Active, not recruiting
Saint-Etienne, France, 42055
Service de dermatologie Recruiting
Toulouse, France, 31059
Contact: Juliette MAZEREEUW-HAUTIER, Pr       mazereeuw-hautier.j@chu-toulouse.fr   
Contact: Aurélie Avargues       aurelie.avargues@med.chu-tours.fr   
Principal Investigator: Juliette Mazereeuw-Hautier, Pr         
Service de dermatologie Recruiting
Tours, France, 37044
Contact: Gérard LORETTE, Pr       lorette@med.univ-tours.fr   
Contact: Aurélie AVARGUES       aurelie.avargues@med.chu-tours.fr   
Principal Investigator: Annabel MARUANI, Dr         
Sponsors and Collaborators
University Hospital, Tours
  More Information

No publications provided

Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT01364857     History of Changes
Other Study ID Numbers: PHRN09 - GL / CONAPE
Study First Received: May 31, 2011
Last Updated: November 8, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Klippel-Trenaunay-Weber Syndrome
Sturge-Weber Syndrome
Neurocutaneous Syndromes
Brain Stem Infarctions
Port-Wine Stain
Angiomatosis
Vascular Diseases
Cardiovascular Diseases
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Nervous System Diseases
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Stroke
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
GTPase-Activating Proteins
GTP Phosphohydrolase Activators
Enzyme Activators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014