A Prospective Longitudinal Study to Identify Biomarkers in Children With Hemangiomas

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

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.

Study Overview

• Status: Completed
• Conditions: Hemangioma
• Intervention / Treatment: Procedure: Urine collection and ultrasonography; Procedure: Urine collection

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 Type: Observational
• Enrollment (Actual): 68

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 5 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children with hemangiomas and children without hemangiomas will be enrolled from Hemangioma and Vascular Malformation Clinic and Ambulatory Pediatric Clinics.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hemangioma; Identify biomarkers in children with hemangiomas.	Procedure: Urine collection and ultrasonography; Bagged urine collection and ultrasound at each visit
Without Hemangioma; Age-matched controlled group without hemangioma.	Procedure: Urine collection; Bagged urine collection

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Gayle Gordillo
• Collaborators: Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2010
• Primary Completion (Actual): December 15, 2015
• Study Completion (Actual): January 10, 2017

Study Registration Dates

• First Submitted: January 13, 2012
• First Submitted That Met QC Criteria: May 10, 2012
• First Posted (Estimate): May 15, 2012

Study Record Updates

• Last Update Posted (Actual): December 14, 2021
• Last Update Submitted That Met QC Criteria: December 13, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Hemangioma
• Other Study ID Numbers: 10-00482