NCT01598116已完成不适用
A Prospective Longitudinal Study to Identify Biomarkers in Children With Hemangiomas.
Gayle Gordillo1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2010年12月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Chemically modified DNA
研究概览
简要总结
Current treatment options for hemangiomas, such as propranolol, steroids and interferon, all have the potential for significantly harmful side effects. The purpose of this study is to identify potential biomarkers that can be used to design clinical trials and accelerate the delivery of new treatment alternatives to children with hemangiomas.
详细描述
Urine will be collected from children with hemangiomas and age-matched healthy controls at 2,4,6,9,12,18 and 24 months of age. Children with hemangiomas will also have ultrasound examination performed at each visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Weeks 至 5 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children with hemangioma
- •Age ≤ 5 months
- •Doppler ultrasound confirmed diagnosis of hemangioma to rule out presence of vascular malformation
- •Age matched control ≤ 5 months (no hemangioma)
排除标准
- •Hemangioma treated prior to or during study period with laser, steroids, interferon, or propranolol, or any other drug or device intended to inhibit the growth of the hemangioma
- •Known history of sickle cell anemia, thalassemia, or other hemoglobinopathy
- •Hemangioma presented as fully formed at birth consistent with rapidly involuting or non-involuting congenital hemangioma
- •PHACES syndrome- posterior fossa malformations, hemangioma, arterial anomalies, cardiac anomalies, eye abnormalities, sternal anomalies
- •Parent/guardian unable to speak english to provide informed consent and no interpreter is present
结局指标
主要结局
Chemically modified DNA
时间窗: 6 months
Determine whether changes in urinary 8-OHdG can be used as biomarkers for HE growth and involution.
次要结局
- Blood flow velocity(6 months)
研究者
Gayle Gordillo
Associate Professor
Ohio State University
研究点 (1)
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