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A Prospective Longitudinal Study to Identify Biomarkers in Children With Hemangiomas

NCT ID: NCT01598116

Last Updated: 2021-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-12

Study Completion Date

2017-01-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hemangioma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Hemangioma

Identify biomarkers in children with hemangiomas.

Urine collection and ultrasonography

Intervention Type PROCEDURE

Bagged urine collection and ultrasound at each visit

Without Hemangioma

Age-matched controlled group without hemangioma.

Urine collection

Intervention Type PROCEDURE

Bagged urine collection

Interventions

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Urine collection and ultrasonography

Bagged urine collection and ultrasound at each visit

Intervention Type PROCEDURE

Urine collection

Bagged urine collection

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

4 Weeks

Maximum Eligible Age

5 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nationwide Children's Hospital

OTHER

Sponsor Role collaborator

Gayle Gordillo

OTHER

Sponsor Role lead

Responsible Party

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Gayle Gordillo

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Gayle M Gordillo, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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10-00482

Identifier Type: -

Identifier Source: org_study_id