A Prospective Longitudinal Study to Identify Biomarkers in Children With Hemangiomas
This trial is active, not recruiting.
|Treatments||urine collection and ultrasonography, urine collection|
|Collaborator||Nationwide Children's Hospital|
|Start date||December 2010|
|End date||December 2016|
|Trial size||60 participants|
|Trial identifier||NCT01598116, 10-00482|
Current treatment options for hemangiomas, such as propranolol, steroids and interferon, all have the potential for significantly harmful side effects. The purpose of this study is to identify potential biomarkers that can be used to design clinical trials and accelerate the delivery of new treatment alternatives to children with hemangiomas.
|Observational model||case control|
Identify biomarkers in children with hemangiomas.
Age-matched controlled group without hemangioma.
Chemically modified DNA
time frame: 6 months
Blood flow velocity
time frame: 6 months
Male or female participants up to 5 months old.
Inclusion Criteria: - Children with hemangioma - Age ≤ 5 months - Doppler ultrasound confirmed diagnosis of hemangioma to rule out presence of vascular malformation - Age matched control ≤ 5 months (no hemangioma) Exclusion Criteria: - Hemangioma treated prior to or during study period with laser, steroids, interferon, or propranolol, or any other drug or device intended to inhibit the growth of the hemangioma - Known history of sickle cell anemia, thalassemia, or other hemoglobinopathy - Hemangioma presented as fully formed at birth consistent with rapidly involuting or non-involuting congenital hemangioma - PHACES syndrome- posterior fossa malformations, hemangioma, arterial anomalies, cardiac anomalies, eye abnormalities, sternal anomalies - Parent/guardian unable to speak english to provide informed consent and no interpreter is present
|Official title||A Prospective Longitudinal Study to Identify Biomarkers in Children With Hemangiomas.|
|Principal investigator||Gayle M Gordillo, MD|
|Description||Urine will be collected from children with hemangiomas and age-matched healthy controls at 2,4,6,9,12,18 and 24 months of age. Children with hemangiomas will also have ultrasound examination performed at each visit.|
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