A Prospective Longitudinal Study to Identify Biomarkers in Children With Hemangiomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01598116
Recruitment Status : Active, not recruiting
First Posted : May 15, 2012
Last Update Posted : March 22, 2018
Nationwide Children's Hospital
Information provided by (Responsible Party):
Gayle Gordillo, Ohio State University

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.

Condition or disease Intervention/treatment
Hemangioma 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
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Prospective Longitudinal Study to Identify Biomarkers in Children With Hemangiomas.
Study Start Date : December 2010
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. Chemically modified DNA [ Time Frame: 6 months ]
    Determine whether changes in urinary 8-OHdG can be used as biomarkers for HE growth and involution.

Secondary Outcome Measures :
  1. 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.

Biospecimen Retention:   Samples Without DNA
serum and urine

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01598116

United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Gayle Gordillo
Nationwide Children's Hospital
Principal Investigator: Gayle M Gordillo, MD Ohio State University

Responsible Party: Gayle Gordillo, Associate Professor, Ohio State University Identifier: NCT01598116     History of Changes
Other Study ID Numbers: 10-00482
First Posted: May 15, 2012    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: April 2017

Additional relevant MeSH terms:
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type