A Prospective Longitudinal Study to Identify Biomarkers in Children With Hemangiomas

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective Longitudinal Study to Identify Biomarkers in Children With Hemangiomas.

Conditions
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Hemangioma

Intervention / Treatment
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* Procedure: Urine collection and ultrasonography
* Procedure: Urine collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Weeks
Maximum Age: 5 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hemangioma<br>Identify biomarkers in children with hemangiomas. | Procedure: Urine collection and ultrasonography<br>* Bagged urine collection and ultrasound at each visit<br>|
| Without Hemangioma<br>Age-matched controlled group without hemangioma. | Procedure: Urine collection<br>* Bagged urine collection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chemically modified DNA | Determine whether changes in urinary 8-OHdG can be used as biomarkers for HE growth and involution. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood flow velocity | Obtain Doppler ultrasound measurements of HE blood flow velocity and size on the same days as serum and urine specimen collection to determine whether changes in blood flow velocity and size correlate with changes in 8-OHdG production. | 6 months |