A Prospective Longitudinal Study to Identify Biomarkers in Children With Hemangiomas

Gayle Gordillo

Status

Completed

Conditions

Hemangioma

Treatments

Procedure: Urine collection

Procedure: Urine collection and ultrasonography

Study type

Observational

Funder types

Other

Identifiers

NCT01598116

10-00482

Details and patient eligibility

About

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.

Full 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.

Enrollment

68 patients

Sex

All

Ages

4 weeks to 5 months old

Volunteers

Accepts Healthy Volunteers

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