Clinical trial NCT00374335: Incidence of Hepatic Hemangiomatosis in Patients With Cutaneous Hemangiomas
Official title: Multiple Hemangiomas and Large Cutaneous Hemangiomas of Infancy: Incidence of Hepatic Hemangiomatosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemangioma
Keywords: prospective cohort study
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
Collaborators: name: Medical College of Wisconsin
name: University of California, San Francisco
name: Columbia University
name: Baylor College of Medicine
name: Northwestern University
name: St. Justine's Hospital
name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
First posted: 2006-09-11
Enrollment: 261
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.

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 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

Primary outcomes:
measure: Frequency of Hepatic Hemangiomas Identified on Abdominal Ultrasound
timeFrame: 2 years
measure: Presence of Hepatic Hemangiomas on Abdominal Ultrasound
timeFrame: 2 years
Secondary outcomes:
measure: Risk Factors Associated With the Development of Hepatic Hemangiomas
timeFrame: 2 years
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Medical College of Wisconsin
name: Beth A Drolet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Maria Garzon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Mercy Hospital Kansas City
name: Kimberly A Horii, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor College of Medicine
name: Denise Metry, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University-Children's Memorial Hospital
name: Sarah Chamlin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Ilona J Frieden, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Justine's Hospital
name: Julie Powell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Cincinnati
name: Anne Lucky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de la Santa Crue i Santa Pau
name: Eulalia Baselga, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chiller KG, Passaro D, Frieden IJ. Hemangiomas of infancy: clinical characteristics, morphologic subtypes, and their relationship to race, ethnicity, and sex. Arch Dermatol. 2002 Dec;138(12):1567-76. doi: 10.1001/archderm.138.12.1567.
citation: Boon LM, Burrows PE, Paltiel HJ, Lund DP, Ezekowitz RA, Folkman J, Mulliken JB. Hepatic vascular anomalies in infancy: a twenty-seven-year experience. J Pediatr. 1996 Sep;129(3):346-54. doi: 10.1016/s0022-3476(96)70065-3.
citation: Metry DW, Hawrot A, Altman C, Frieden IJ. Association of solitary, segmental hemangiomas of the skin with visceral hemangiomatosis. Arch Dermatol. 2004 May;140(5):591-6. doi: 10.1001/archderm.140.5.591.
citation: Hughes JA, Hill V, Patel K, Syed S, Harper J, De Bruyn R. Cutaneous haemangioma: prevalence and sonographic characteristics of associated hepatic haemangioma. Clin Radiol. 2004 Mar;59(3):273-80. doi: 10.1016/S0009-9260(03)00267-8.
citation: Bruckner AL, Frieden IJ. Hemangiomas of infancy. J Am Acad Dermatol. 2003 Apr;48(4):477-93; quiz 494-6. doi: 10.1067/mjd.2003.200.
citation: Horii KA, Drolet BA, Baselga E, Frieden IJ, Metry DW, Morel KD, Newell BD, Nopper AJ, Garzon MC; Hemangioma Investigator Group. Risk of hepatic hemangiomas in infants with large hemangiomas. Arch Dermatol. 2010 Feb;146(2):201-3. doi: 10.1001/archdermatol.2009.391. No abstract available.