This trial is active, not recruiting.

Condition hemangioma
Treatments urine collection and ultrasonography, urine collection
Sponsor Gayle Gordillo
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Identify biomarkers in children with hemangiomas.
urine collection and ultrasonography
Bagged urine collection and ultrasound at each visit
Age-matched controlled group without hemangioma.
urine collection
Bagged urine collection

Primary Outcomes

Chemically modified DNA
time frame: 6 months

Secondary Outcomes

Blood flow velocity
time frame: 6 months

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Ohio State University.