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| 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 Hospital St. Justine Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
| Information provided by: | Children's Mercy Hospital Kansas City |
| ClinicalTrials.gov Identifier: | NCT00374335 |
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 |
| Study Type: | Interventional |
| Study Design: | Screening, Non-Randomized, Open Label, Active Control, Single Group Assignment |
| Official Title: | Multiple Hemangiomas and Large Cutaneous Hemangiomas of Infancy: Incidence of Hepatic Hemangiomatosis |
| Estimated Enrollment: | 325 |
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:
Exclusion Criteria:
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
| Study ID Numbers: | 06 02 029E |
| Study First Received: | September 7, 2006 |
| Last Updated: | January 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00374335 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
prospective cohort study |
|
Neoplasms Neoplasms by Histologic Type Neoplasms, Vascular Tissue Hemangioma |