Incidence of Hepatic Hemangiomatosis in Patients With Cutaneous Hemangiomas

This study has been completed.
Sponsor:
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 (Responsible Party):
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00374335
First received: September 7, 2006
Last updated: September 12, 2011
Last verified: September 2011
  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
Other: Dermatologic Examination

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
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:
  • Frequency of Hepatic Hemangiomas Identified on Abdominal Ultrasound [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Risk Factors Associated With the Development of Hepatic Hemangiomas [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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


Enrollment: 261
Study Start Date: September 2006
Study Completion Date: December 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
infants with cutaneous hemangiomas Procedure: abdominal ultrasound
abdominal ultrasound to detect hepatic hemangiomas
Other: Dermatologic Examination
Complete dermatologic examination

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT00374335     History of Changes
Other Study ID Numbers: 06 02 029E
Study First Received: September 7, 2006
Results First Received: August 9, 2011
Last Updated: September 12, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 20, 2014