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Completed

NCT Number: NCT01598116

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.

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Key information

Conditions

Hemangioma Neoplasms Neoplasms by Histologic Type Neoplasms, Vascular Tissue

Age range

4 week–5 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urine collection and ultrasonography

Procedure

Bagged urine collection and ultrasound at each visit

Urine collection

Procedure

Bagged urine collection

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Gayle Gordillo

Other

Collaborators

  • Nationwide Children's Hospital

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2017
First posted
May 15, 2012
Registry last updated
Dec 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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