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Completed

NCT Number: NCT00374335

Incidence of Hepatic Hemangiomatosis in Patients With Cutaneous Hemangiomas

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.

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Key information

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abdominal ultrasound

Procedure

abdominal ultrasound to detect hepatic hemangiomas

Dermatologic Examination

Other

Complete dermatologic examination

Primary outcomes

  1. Frequency of Hepatic Hemangiomas Identified on Abdominal Ultrasound

    Time frame: 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. Presence of Hepatic Hemangiomas on Abdominal Ultrasound

    Time frame: 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

Secondary outcomes

  1. Risk Factors Associated With the Development of Hepatic Hemangiomas

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Collaborators

  • Baylor College of Medicine
  • Columbia University
  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  • Medical College of Wisconsin
  • Northwestern University
  • St. Justine's Hospital
  • University of California, San Francisco

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Sep 11, 2006
Registry last updated
Sep 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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