A Prospective Longitudinal Study to Identify Biomarkers in Children With Hemangiomas

Completed

• Conditions: Hemangioma
• Interventions: Procedure: Urine collection; Procedure: Urine collection and ultrasonography

• Registration Number: NCT01598116
• Lead Sponsor: Gayle Gordillo

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.

Study Timeline

• Study Start: 2010-12-12
• Study First Submitted: 2012-01-13
• Study First Submitted QC: 2012-05-10
• Study First Posted: 2012-05-15
• Primary Completion: 2015-12-15
• Study Completion: 2017-01-10
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-13
• Last Update Posted: 2021-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Without Hemangioma	Urine collection	Age-matched controlled group without hemangioma.
Hemangioma	Urine collection and ultrasonography	Identify biomarkers in children with hemangiomas.

Primary Outcome Measures

Name	Time	Method
Chemically modified DNA	6 months	Determine whether changes in urinary 8-OHdG can be used as biomarkers for HE growth and involution.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States