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A Prospective Longitudinal Study to Identify Biomarkers in Children With Hemangiomas

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ClinicalTrials.gov Identifier: NCT01598116
Recruitment Status : Active, not recruiting
First Posted : May 15, 2012
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
Nationwide Children's Hospital
Information provided by (Responsible Party):
Gayle Gordillo, Ohio State University

January 13, 2012
May 15, 2012
March 22, 2018
December 2010
December 2017   (Final data collection date for primary outcome measure)
Chemically modified DNA [ Time Frame: 6 months ]
Determine whether changes in urinary 8-OHdG can be used as biomarkers for HE growth and involution.
Not Provided
Complete list of historical versions of study NCT01598116 on ClinicalTrials.gov Archive Site
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.
Not Provided
Not Provided
Not Provided
 
A Prospective Longitudinal Study to Identify Biomarkers in Children With Hemangiomas
A Prospective Longitudinal Study to Identify Biomarkers in Children With Hemangiomas.
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.
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.
Observational
Observational Model: Case-Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
serum and urine
Non-Probability Sample
Children with hemangiomas and children without hemangiomas will be enrolled from Hemangioma and Vascular Malformation Clinic and Ambulatory Pediatric Clinics.
Hemangioma
  • Procedure: Urine collection and ultrasonography
    Bagged urine collection and ultrasound at each visit
  • Procedure: Urine collection
    Bagged urine collection
  • Hemangioma
    Identify biomarkers in children with hemangiomas.
    Intervention: Procedure: Urine collection and ultrasonography
  • Without Hemangioma
    Age-matched controlled group without hemangioma.
    Intervention: Procedure: Urine collection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
Same as current
December 2018
December 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 5 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01598116
10-00482
No
Not Provided
Not Provided
Gayle Gordillo, Ohio State University
Gayle Gordillo
Nationwide Children's Hospital
Principal Investigator: Gayle M Gordillo, MD Ohio State University
Ohio State University
April 2017