French National Cohort of Children With Port Wine Stain (CONAPE)
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| ClinicalTrials.gov Identifier: NCT01364857 |
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Recruitment Status : Unknown
Verified February 2017 by University Hospital, Tours.
Recruitment status was: Active, not recruiting
First Posted : June 3, 2011
Last Update Posted : February 24, 2017
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Port Wine Stain Klippel Trenaunay Syndrome Parkes Weber Syndrome | Genetic: search for polymorphisms of RASA1 gene | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 150 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (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" |
| Actual Study Start Date : | November 2010 |
| Estimated Primary Completion Date : | November 2019 |
| Estimated Study Completion Date : | November 2019 |
| Arm | Intervention/treatment |
|---|---|
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PWS cohort
search for polymorphisms of RASA1 gene
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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 |
- complicated evolution (defined as: vascular, orthopedic or systemic involvement linked with the port wine stain) [ Time Frame: during the 5 years of follow up ]
- mutations of RASA 1 gene [ Time Frame: during the 5 years of follow up ]
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| 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01364857
| France | |
| 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 | |
| Study Chair: | Violaine MIZZI | University Hospital, Tours |
| Responsible Party: | University Hospital, Tours |
| ClinicalTrials.gov Identifier: | NCT01364857 |
| Other Study ID Numbers: |
PHRN09 - GL / CONAPE |
| First Posted: | June 3, 2011 Key Record Dates |
| Last Update Posted: | February 24, 2017 |
| Last Verified: | February 2017 |
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port wine stain of a limb |
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Hemangioma, Capillary Sturge-Weber Syndrome Brain Stem Infarctions Klippel-Trenaunay-Weber Syndrome Port-Wine Stain Syndrome Disease Pathologic Processes Skin Abnormalities Congenital Abnormalities Skin Diseases Hemangioma Neoplasms, Vascular Tissue Neoplasms by Histologic Type Neoplasms |
Brain Infarction Brain Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Stroke Vascular Diseases Cardiovascular Diseases Infarction Ischemia Necrosis Angiomatosis Neurocutaneous Syndromes GTPase-Activating Proteins |