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Incidence of Hepatic Hemangiomatosis in Patients With Cutaneous Hemangiomas

2011年9月12日 更新者:Children's Mercy Hospital Kansas City

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

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

261

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Missouri
      • Kansas City、Missouri、美国、64108
        • Children's Mercy Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

不超过 6个月 (孩子)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Infants greater than 6 months of age

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:放映
  • 分配:非随机化
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:infants with cutaneous hemangiomas
abdominal ultrasound to detect hepatic hemangiomas
Complete dermatologic examination

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Frequency of Hepatic Hemangiomas Identified on Abdominal Ultrasound
大体时间: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
2 years
Presence of Hepatic Hemangiomas on Abdominal Ultrasound
大体时间: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
2 years

次要结果测量

结果测量
措施说明
大体时间
Risk Factors Associated With the Development of Hepatic Hemangiomas
大体时间:2 years
Which participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least 1 large cutaneous hemangioma) were found to have hepatic hemangiomas on abdominal ultrasound
2 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Maria Garzon, MD、Columbia University
  • 首席研究员:Denise Metry, MD、Baylor College of Medicine
  • 首席研究员:Anne Lucky, MD、Children's Hospital of Cincinnati
  • 首席研究员:Ilona J Frieden, MD、University of California, San Francisco
  • 首席研究员:Kimberly A Horii, MD、Children's Mercy Hospital Kansas City
  • 首席研究员:Sarah Chamlin, MD、Northwestern University-Children's Memorial Hospital
  • 首席研究员:Julie Powell, MD、St. Justine's Hospital
  • 首席研究员:Eulalia Baselga, MD、Hospital de la Santa Crue i Santa Pau

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2006年9月1日

初级完成 (实际的)

2008年6月1日

研究完成 (实际的)

2009年12月1日

研究注册日期

首次提交

2006年9月7日

首先提交符合 QC 标准的

2006年9月8日

首次发布 (估计)

2006年9月11日

研究记录更新

最后更新发布 (估计)

2011年9月16日

上次提交的符合 QC 标准的更新

2011年9月12日

最后验证

2011年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • 06 02 029E

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

abdominal ultrasound的临床试验

3
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