French National Prospective Cohort of Children With Port Wine Stain on a Limb = "Cohorte Nationale d'Enfants Avec Angiome Plan de Membre inférieur"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 22
- 主要终点
- Complicated evolution (defined as: vascular, orthopedic or systemic involvement linked with the port wine stain)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •child with orthopedic impairment with no link with the port wine stain
结局指标
主要结局
Complicated evolution (defined as: vascular, orthopedic or systemic involvement linked with the port wine stain)
时间窗: during the 5 years of follow up
Complicated evolution (defined as: vascular, orthopedic or systemic involvement linked with the port wine stain)
次要结局
- Mutations of RASA 1 gene(during the 5 years of follow up)