Clinical trial · Observational
A Prospective Longitudinal Study to Identify Biomarkers in Children With Hemangiomas
A Prospective Longitudinal Study to Identify Biomarkers in Children With Hemangiomas.
NCT01598116CI-TRIAL-00055516completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hemangioma | Hemangioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Urine collection | Procedure | — | UNRESOLVED |
| Urine collection and ultrasonography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Hemangioma
- description
- Identify biomarkers in children with hemangiomas.
- interventionNames
- Procedure: Urine collection and ultrasonography
- label
- Without Hemangioma
- description
- Age-matched controlled group without hemangioma.
- interventionNames
- Procedure: Urine collection
Primary outcomes (1)
- measure
- Chemically modified DNA
- timeFrame
- 6 months
- description
- Determine whether changes in urinary 8-OHdG can be used as biomarkers for HE growth and involution.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Weeks
- Maximum age
- 5 Months
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.