A Prospective Longitudinal Study to Identify Biomarkers in Children With Hemangiomas

Hemangioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01598116
• Other study ID #: 10-00482
• Status: Completed
• Start date: December 12, 2010
• Est. completion date: January 10, 2017

Study information

• Verified date: December 2021
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: January 10, 2017
• Est. primary completion date: December 15, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 5 Months

Eligibility

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

Related Conditions & MeSH terms

• Hemangioma

Intervention

Procedure:
• Urine collection and ultrasonography
Bagged urine collection and ultrasound at each visit
• Urine collection
Bagged urine collection

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Gayle Gordillo	Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chemically modified DNA	Determine whether changes in urinary 8-OHdG can be used as biomarkers for HE growth and involution.	6 months
Secondary	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