Incidence of Hepatic Hemangiomatosis in Patients With Cutaneous Hemangiomas
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
- 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
- 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 |
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| United States, Missouri | |
| Children's Mercy Hospital | |
| Kansas City, Missouri, United States, 64108 | |
| 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 May 21, 2013