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临床试验/NCT00374335
NCT00374335已完成不适用

Multiple Hemangiomas and Large Cutaneous Hemangiomas of Infancy: Incidence of Hepatic Hemangiomatosis

Children's Mercy Hospital Kansas City2 个研究点 分布在 1 个国家目标入组 261 人开始时间: 2006年9月1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
261
试验地点
2
主要终点
Frequency of Hepatic Hemangiomas Identified on Abdominal Ultrasound

研究概览

简要总结

This study will attempt to determine how common liver hemangiomas are in children with infantile hemangiomas by comparing liver ultrasound results in patients with 1-4 cutaneous hemangiomas, 5 or more cutaneous hemangiomas, or at least 1 large hemangioma versus ultrasound results in children without hemangiomas. Other objectives of the study include identifying specific risk factors in patients who have liver hemangiomas and identifying risk factors in children with symptomatic liver hemangiomas.

详细描述

Hemangioma of infancy is the most common tumor of childhood occurring in 4% to 10% of infants. While most hemangiomas are benign in behavior and involute spontaneously, some can cause significant morbidity due to their location and size. In addition, some hemangiomas may be associated with extracutaneous hemangiomas that result in significant morbidity. Certain "high risk" hemangiomas of infancy, specifically multiple cutaneous hemangiomas or a solitary large hemangioma, have been associated with hepatic hemangiomatosis; however, the exact number or size of the cutaneous lesions at which the risk increases and the protocol for evaluating these patients remain controversial. The true prevalence of hepatic hemangiomatosis is unknown since there have been no large scale prospective studies evaluating clinically asymptomatic patients with cutaneous hemangiomas for the presence of hepatic hemangiomatosis.

One of the primary objectives of this study is to determine the incidence of hepatic hemangiomatosis in patients with hemangiomas of infancy by comparing hepatic ultrasound imaging results of patients with 1-4 cutaneous hemangiomas, 5 or more cutaneous hemangiomas, or at least 1 large hemangioma >30 cm2 versus imaging results in patients without cutaneous hemangiomas. The study will also attempt to identify specific risk factors associated with the development of hepatic hemangiomatosis and to identify associated risk factors in patients with clinically symptomatic hepatic hemangiomatosis.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
— 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infants less than 6 months of age
  • clinical diagnosis of 1-4 cutaneous hemangiomas
  • clinical diagnosis of 5 or more cutaneous hemangiomas
  • clinical diagnosis of at least 1 large cutaneous hemangioma greater than 30 cm2

排除标准

  • Infants greater than 6 months of age

结局指标

主要结局

Frequency of Hepatic Hemangiomas Identified on Abdominal Ultrasound

时间窗: 2 years

The number of participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least one large cutaneous hemangioma) who were found to have hepatic hemangiomas on abdominal ultrasound

Presence of Hepatic Hemangiomas on Abdominal Ultrasound

时间窗: 2 years

The number of participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least one large cutaneous hemangioma) who were found to have hepatic hemangiomas on abdominal ultrasound

次要结局

  • Risk Factors Associated With the Development of Hepatic Hemangiomas(2 years)

研究者

发起方
Children's Mercy Hospital Kansas City
申办方类型
Other
责任方
Sponsor

研究点 (2)

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