Vascular Malformations and Abnormalities of Growth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Percent of growth over time
研究概览
简要总结
To take part in this study you/your child have a vascular malformation, a type of blood vessel disorder whose cause is unknown.
The investigators will do this by looking at changes in the genes and proteins in the cells of the malformation as well as normal cells.
The investigators are doing this research because currently there is no known cause of vascular malformations and no way to know whether or not other health problems will occur in addition to the malformation. Through this research we hope to create standard methods for doctors to examine and treat people with vascular anomalies.
详细描述
If you/your child agree to participate
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Informed consent and permission to use or disclose you/your child's health information for reserve purposes will be obtained by the research team. You will receive a copy of the consent form.
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You/your child will be examined by a physician from the research team and interviewed about your medical background and condition every year for five years.
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You/your child will have photographs taken of the affected area at each visit.
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You/your child will have two, one time biopsies or skin samples taken by a dermatologist. Skin areas will be numbed with lidocaine and a 4 or 5 millimeter (or approximately 0.15 to 0.19 inch) sample will be taken in two different locations. The dermatologist taking the skin sample will use every effort to choose an area that can be covered by clothing or kept out of sight to others. The doctor will either use gelfoam or one stitch/suture per biopsy to seal off the area, which helps with healing and preventing bleeding. If a stitch is placed in the biopsy site, another visit about 7-10 days following the procedure will be necessary to remove the stitch.
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You may still participate in the study if you consent to having only one biopsy taken of your affected (lesion) skin and not one of your unaffected (normal) skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than 1 year of age
- •Diagnosis of vascular malformation
- •Each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent. Each patient must also give assent to study participation given they have the cognitive capacity to do so.
排除标准
- •Patients less than 1 year of age
- •Vascular malformations likely to result in poor wound healing or located in areas of the body prone to significant scarring
- •Individuals with vascular malformations and previous diagnosis of disseminated intravascular coagulopathy
结局指标
主要结局
Percent of growth over time
时间窗: 5 years
次要结局
- Patient specific gene and protein expression levels that can distinguish affected from unaffected tissue in patients.(5 years)
研究者
Beth Drolet
Professor and Vice Chairman of Pediatric Dermatology
Medical College of Wisconsin