Hemangioma
Conditions
Brief summary
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
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.
Interventions
PROCEDUREUrine collection and ultrasonography
Bagged urine collection and ultrasound at each visit
PROCEDUREUrine collection
Bagged urine collection
Sponsors
Nationwide Children's Hospital
Gayle Gordillo
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
4 Weeks to 5 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chemically modified DNA | 6 months | Determine whether changes in urinary 8-OHdG can be used as biomarkers for HE growth and involution. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood flow velocity | 6 months | 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. |
Countries
United States
Outcome results
None listed