Incidence of Hepatic Hemangiomatosis in Patients With Cutaneous Hemangiomas
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| First Received Date ICMJE | September 7, 2006 | ||||||||||||||||||||||||||||||||||||
| Last Updated Date | September 12, 2011 | ||||||||||||||||||||||||||||||||||||
| Start Date ICMJE | September 2006 | ||||||||||||||||||||||||||||||||||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
presence of hepatic hemangiomas on abdominal ultrasound | ||||||||||||||||||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT00374335 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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 |
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| Original Secondary Outcome Measures ICMJE |
identify risk factors associated with the development of hepatic hemangiomas | ||||||||||||||||||||||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||||||||||||||||||
| Brief Title ICMJE | Incidence of Hepatic Hemangiomatosis in Patients With Cutaneous Hemangiomas | ||||||||||||||||||||||||||||||||||||
| Official Title ICMJE | Multiple Hemangiomas and Large Cutaneous Hemangiomas of Infancy: Incidence of Hepatic Hemangiomatosis | ||||||||||||||||||||||||||||||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||||||||||||||||||||||||||||||
| Study Phase | Not Provided | ||||||||||||||||||||||||||||||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Screening |
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| Condition ICMJE | Hemangioma | ||||||||||||||||||||||||||||||||||||
| Intervention ICMJE |
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| Study Arm (s) | infants with cutaneous hemangiomas
Interventions:
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||||||||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||||||||||||||||||||||
| Enrollment ICMJE | 261 | ||||||||||||||||||||||||||||||||||||
| Completion Date | December 2009 | ||||||||||||||||||||||||||||||||||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||||||||||||||||||||||
| Ages | up to 6 Months | ||||||||||||||||||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||||||||||||||
| Location Countries ICMJE | United States | ||||||||||||||||||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||||||||||||||||||
| NCT Number ICMJE | NCT00374335 | ||||||||||||||||||||||||||||||||||||
| Other Study ID Numbers ICMJE | 06 02 029E | ||||||||||||||||||||||||||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||||||||||||||||||||||||||
| Responsible Party | Children's Mercy Hospital Kansas City | ||||||||||||||||||||||||||||||||||||
| Study Sponsor ICMJE | Children's Mercy Hospital Kansas City | ||||||||||||||||||||||||||||||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Children's Mercy Hospital Kansas City | ||||||||||||||||||||||||||||||||||||
| Verification Date | September 2011 | ||||||||||||||||||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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