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A Prospective Longitudinal Study to Identify Biomarkers in Children With Hemangiomas

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Ohio State University
Sponsor:
Collaborator:
Nationwide Children's Hospital
Information provided by (Responsible Party):
Gayle Gordillo, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01598116
First received: January 13, 2012
Last updated: April 21, 2014
Last verified: April 2014
  Purpose

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 Intervention
Hemangioma
Procedure: Urine collection and ultrasonography
Procedure: Urine collection

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Prospective Longitudinal Study to Identify Biomarkers in Children With Hemangiomas.

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Chemically modified DNA [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Determine whether changes in urinary 8-OHdG can be used as biomarkers for HE growth and involution.


Secondary Outcome Measures:
  • Blood flow velocity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 60
Study Start Date: December 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 5 Months
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01598116

Contacts
Contact: Bonny Bowen, RN, CCRC 614-722-2689 bonny.bowen@nationwidechildrens.org
Contact: Paulla Davies, CCRC 614-722-2650

Locations
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Gayle Gordillo, MD    614-293-8566    gayle.gordillo@osumc.edu   
Principal Investigator: Gayle M Gordillo, MD         
Sponsors and Collaborators
Gayle Gordillo
Nationwide Children's Hospital
Investigators
Principal Investigator: Gayle M Gordillo, MD Ohio State University
  More Information

No publications provided

Responsible Party: Gayle Gordillo, Associate Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT01598116     History of Changes
Other Study ID Numbers: 10-00482
Study First Received: January 13, 2012
Last Updated: April 21, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 23, 2014