Clinical Trial: A Prospective Longitudinal Study to Identify Biomarkers in Children With Hemangiomas

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

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 Summary: 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.
Sponsor: Gayle Gordillo

Current Primary Outcome: Chemically modified DNA [ Time Frame: 6 months ]

Determine whether changes in urinary 8-OHdG can be used as biomarkers for HE growth and involution.


Original Primary Outcome:

Current Secondary Outcome: Blood flow velocity [ Time Frame: 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.


Original Secondary Outcome:

Information By: Ohio State University

Dates:
Date Received: January 13, 2012
Date Started: December 2010
Date Completion: December 2017
Last Updated: April 3, 2017
Last Verified: April 2017