HemangiomaNCT01598116
A Prospective Longitudinal Study to Identify Biomarkers in Children With Hemangiomas
An observational study of Hemangioma, run by Gayle Gordillo at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 4 weeks to 5 monthsHealthy volunteers can take part
- Conditions the study is for
- Hemangioma
- What is being tested?
- Urine collection and ultrasonography and Urine collection
- Type of treatment
- Surgery or procedure
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2010to 10 Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 weeks to 5 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with hemangiomas and children without hemangiomas will be enrolled from Hemangioma and Vascular Malformation Clinic and Ambulatory Pediatric Clinics.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: 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.
Read the 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.
- Conditions
- Hemangioma
- Being tested
- Urine collection and ultrasonography, Urine collection
- Medical subject headings
- Hemangioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine collection and ultrasonographyProcedure or surgery
Bagged urine collection and ultrasound at each visit
Urine collectionProcedure or surgery
Bagged urine collection
| Study group | Role | What they receive |
|---|---|---|
| Hemangioma | Identify biomarkers in children with hemangiomas. Receives: Procedure: Urine collection and ultrasonography | |
| Without Hemangioma | Age-matched controlled group without hemangioma. Receives: Procedure: Urine collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemically modified DNA
Determine whether changes in urinary 8-OHdG can be used as biomarkers for HE growth and involution.
Measured: 6 months
Secondary outcomes (1)
Blood flow velocity
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study start12 Dec 2010
- Primary completion15 Dec 2015
- Study completion10 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemangiomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gayle Gordillo
- Sponsor type
- University, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Responsible party
- Sponsor-investigator, Gayle Gordillo, Ohio State University
- Investigators
- Gayle M Gordillo, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598116
- Sponsor's protocol ID
- 10-00482
- Status last verified
- Dec 2021
- First submitted
- 13 Jan 2012
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Longitudinal Study to Identify Biomarkers in Children With Hemangiomas.
- ClinicalTrials.gov ID
- NCT01598116
- Acronym / sponsor ID
- 10-00482
- Conditions
- Hemangioma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Gayle GordilloUniversity, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Study start
- 12 Dec 2010 (actual)
- Primary completion
- 15 Dec 2015 (actual)
- Study completion
- 10 Jan 2017 (actual)
- First posted
- 15 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemangioma | – | Procedure: Urine collection and ultrasonographyIdentify biomarkers in children with hemangiomas. |
| Without Hemangioma | – | Procedure: Urine collectionAge-matched controlled group without hemangioma. |
Who may qualify
- Ages
- 4 weeks to 5 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with hemangiomas and children without hemangiomas will be enrolled from Hemangioma and Vascular Malformation Clinic and Ambulatory Pediatric Clinics.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urine collection and ultrasonographyBagged urine collection and ultrasound at each visit | Procedure or surgery | Hemangioma |
| Urine collectionBagged urine collection | Procedure or surgery | Without Hemangioma |
Primary outcome
Chemically modified DNA
Time frame: 6 months
Determine whether changes in urinary 8-OHdG can be used as biomarkers for HE growth and involution.
1 secondary outcome
Blood flow velocity
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gayle M Gordillo, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemangioma, run by Gayle Gordillo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chemically modified DNA (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2021.