A Prospective Longitudinal Study to Identify Biomarkers in Children With Hemangiomas

NCT01598116 | Completed

• 1 other identifier: 10-00482
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemangioma

Outcome Measures

Primary Outcomes (1)

• Chemically modified DNA

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

  6 months

Secondary Outcomes (1)

• Blood flow velocity

  6 months

Study Arms (2)

Hemangioma

Identify biomarkers in children with hemangiomas.

Procedure: Urine collection and ultrasonography

Without Hemangioma

Age-matched controlled group without hemangioma.

Procedure: Urine collection

Interventions

Urine collection and ultrasonography PROCEDURE

Bagged urine collection and ultrasound at each visit

Hemangioma

Urine collection PROCEDURE

Bagged urine collection

Without Hemangioma

Eligibility Criteria

• Age: 4 Weeks - 5 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Gayle Gordillo: lead
• Nationwide Children's Hospital: collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and urine

MeSH Terms

Conditions

Hemangioma

Interventions

Urine Specimen Collection; High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Gayle M Gordillo, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 13, 2012
• First Posted: May 15, 2012
• Study Start: December 12, 2010
• Primary Completion: December 15, 2015
• Study Completion: January 10, 2017
• Last Updated: December 14, 2021

Record last verified: 2021-12

Locations

US (1)