Incidence of Hepatic Hemangiomatosis in Patients With Cutaneous Hemangiomas
Primary Purpose
Hemangioma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
abdominal ultrasound
Dermatologic Examination
Sponsored by
About this trial
This is an interventional screening trial for Hemangioma focused on measuring prospective cohort study
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
Sites / Locations
- Children's Mercy Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
infants with cutaneous hemangiomas
Arm Description
Outcomes
Primary Outcome Measures
Frequency of Hepatic Hemangiomas Identified on Abdominal Ultrasound
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
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
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
Full Information
NCT ID
NCT00374335
First Posted
September 7, 2006
Last Updated
September 12, 2011
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, St. Justine's Hospital, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1. Study Identification
Unique Protocol Identification Number
NCT00374335
Brief Title
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
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the 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, St. Justine's Hospital, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemangioma
Keywords
prospective cohort study
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
261 (Actual)
8. Arms, Groups, and Interventions
Arm Title
infants with cutaneous hemangiomas
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
abdominal ultrasound
Intervention Description
abdominal ultrasound to detect hepatic hemangiomas
Intervention Type
Other
Intervention Name(s)
Dermatologic Examination
Intervention Description
Complete dermatologic examination
Primary Outcome Measure Information:
Title
Frequency of Hepatic Hemangiomas Identified on Abdominal Ultrasound
Description
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
Time Frame
2 years
Title
Presence of Hepatic Hemangiomas on Abdominal Ultrasound
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Risk Factors Associated With the Development of Hepatic Hemangiomas
Description
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
Time Frame
2 years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth A Drolet, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria Garzon, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kimberly A Horii, MD
Organizational Affiliation
Children's Mercy Hospital Kansas City
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Denise Metry, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sarah Chamlin, MD
Organizational Affiliation
Northwestern University-Children's Memorial Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ilona J Frieden, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julie Powell, MD
Organizational Affiliation
St. Justine's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anne Lucky, MD
Organizational Affiliation
Children's Hospital of Cincinnati
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eulalia Baselga, MD
Organizational Affiliation
Hospital de la Santa Crue i Santa Pau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12472344
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.
Results Reference
background
PubMed Identifier
8804322
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.
Results Reference
background
PubMed Identifier
15148105
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.
Results Reference
background
PubMed Identifier
15037141
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.
Results Reference
background
PubMed Identifier
12664009
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.
Results Reference
background
PubMed Identifier
20157038
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.
Results Reference
derived
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Incidence of Hepatic Hemangiomatosis in Patients With Cutaneous Hemangiomas
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