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Incidence of Hepatic Hemangiomatosis in Patients With Cutaneous Hemangiomas
This study is ongoing, but not recruiting participants.
First Received: September 7, 2006   Last Updated: January 6, 2009   History of Changes
Sponsor: Children's Mercy Hospital Kansas City
Collaborators: Medical College of Wisconsin
University of California, San Francisco
Columbia University
Baylor College of Medicine
Northwestern University
Hospital St. Justine
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Information provided by: Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT00374335
  Purpose

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.


Condition Intervention
Hemangioma
Procedure: abdominal ultrasound

Study Type: Interventional
Study Design: Screening, Non-Randomized, Open Label, Active Control, Single Group Assignment
Official Title: Multiple Hemangiomas and Large Cutaneous Hemangiomas of Infancy: Incidence of Hepatic Hemangiomatosis

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • presence of hepatic hemangiomas on abdominal ultrasound

Secondary Outcome Measures:
  • identify risk factors associated with the development of hepatic hemangiomas

Estimated Enrollment: 325
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00374335

Locations
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Medical College of Wisconsin
University of California, San Francisco
Columbia University
Baylor College of Medicine
Northwestern University
Hospital St. Justine
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
Principal Investigator: Beth A Drolet, MD Medical College of Wisconsin
Principal Investigator: Maria Garzon, MD Columbia University
Principal Investigator: Kimberly A Horii, MD Children's Mercy Hospital
Principal Investigator: Denise Metry, MD Baylor College of Medicine
Principal Investigator: Sarah Chamlin, MD Northwestern University-Children's Memorial Hospital
Principal Investigator: Ilona J Frieden, MD University of California, San Francisco
Principal Investigator: Julie Powell, MD Hospital St. Justine
Principal Investigator: Anne Lucky, MD Children's Hospital of Cincinnati
Principal Investigator: Eulalia Baselga, MD Hospital de la Santa Crue i Santa Pau
  More Information

Publications:
Study ID Numbers: 06 02 029E
Study First Received: September 7, 2006
Last Updated: January 6, 2009
ClinicalTrials.gov Identifier: NCT00374335     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
prospective cohort study

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue
Hemangioma

ClinicalTrials.gov processed this record on February 08, 2010