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

September 7, 2006
September 12, 2011
September 2006
June 2008   (final data collection date for primary outcome measure)
  • 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
presence of hepatic hemangiomas on abdominal ultrasound
Complete list of historical versions of study NCT00374335 on ClinicalTrials.gov Archive Site
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
identify risk factors associated with the development of hepatic hemangiomas
Not Provided
Not Provided
 
Incidence of Hepatic Hemangiomatosis in Patients With Cutaneous Hemangiomas
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Hemangioma
  • Procedure: abdominal ultrasound
    abdominal ultrasound to detect hepatic hemangiomas
  • Other: Dermatologic Examination
    Complete dermatologic examination
infants with cutaneous hemangiomas
Interventions:
  • Procedure: abdominal ultrasound
  • Other: Dermatologic Examination

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
261
December 2009
June 2008   (final data collection date for primary outcome measure)

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
Both
up to 6 Months
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00374335
06 02 029E
Yes
Children's Mercy Hospital Kansas City
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
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
Children's Mercy Hospital Kansas City
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP