NCT00911781

Brief Summary

One of the most important and unique characteristics of infantile hemangiomas is their dramatic growth during early infancy. Most hemangiomas are either absent at birth or barely evident as a small scratch or bruise-like area. A recent study emphasized how early hemangioma growth occurs. In this study by 3 months of age, hemangiomas had reached 80% of their final size, and by 5 months of age, 80% had already stopped growing. Unfortunately the average age when most infants are seen by specialists is often at 5 months of age or later, a time when most growth is already completed. Researchers at the University of California, San Francisco, the Medical College of Wisconsin, and at the Mayo Clinic are interested in studying hemangioma growth at even earlier ages, before 3 months of age, which is before most patients are ever seen by dermatologists or other specialists. For this study are requesting that parents of children older than 3 months of age with hemangiomas send us a series of photographs of their child which demonstrates this early growth. Ideally the photographs would show your child (including the area of the hemangioma of course) at weekly or every other week intervals up until age least 3 to 6 months of age. This will probably not be difficult if the hemangioma is on the face but we would be interested in other body locations as well, if available. We are using these photographs to analyze early hemangioma growth patterns, to see if there is a period of especially rapid growth, and to help determine if there is a specific time before which specialty referral should occur. We are interested in all sizes of hemangiomas, from small to large. Of greatest importance is that the photos be at frequent intervals (every 1 to 2 weeks is ideal) and of sufficient quality to be able to evaluate the appearance of the hemangioma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2009

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 2, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 5, 2013

Status Verified

February 1, 2013

Enrollment Period

2.2 years

First QC Date

May 29, 2009

Last Update Submit

February 4, 2013

Conditions

Keywords

Infantile hemangioma

Outcome Measures

Primary Outcomes (1)

  • hemangioma growth

    up to 8 weeks

Study Arms (1)

Infants with infantile hemangiomas

Other: No intervention

Interventions

We are only asking for photographs from parents.

Infants with infantile hemangiomas

Eligibility Criteria

Age3 Months - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients are being recruited from a national hemangioma support website (NOVA)and from community clinics atthe University of California, San Francisco. We hope to reach more interested parents through registering our protocol.

You may qualify if:

  • Children older than 3 months of age who have or have had a diagnosis of an infantile hemangioma. The parents of these children will be able to provide us with frequent (weekly to biweekly) photographs of the patient's hemangioma(s) during the first 3-6 months of life.
  • These hemangiomas must have a superficial component that can be seen. Parents must consent to the use of their child's photographs in this study.

You may not qualify if:

  • Current age less than 3 months. Patient who do not have an infantile hemangioma (as determined by the investigators). Patients whose photographs are not of sufficient quality or frequency in order to be evaluated for this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California, San Francisco

San Francisco, California, 94115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55901, United States

Location

Related Publications (1)

  • Chang LC, Haggstrom AN, Drolet BA, Baselga E, Chamlin SL, Garzon MC, Horii KA, Lucky AW, Mancini AJ, Metry DW, Nopper AJ, Frieden IJ; Hemangioma Investigator Group. Growth characteristics of infantile hemangiomas: implications for management. Pediatrics. 2008 Aug;122(2):360-7. doi: 10.1542/peds.2007-2767.

    PMID: 18676554BACKGROUND

Related Links

MeSH Terms

Conditions

Hemangioma, Capillary

Condition Hierarchy (Ancestors)

HemangiomaNeoplasms, Vascular TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Ilona J Frieden, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2009

First Posted

June 2, 2009

Study Start

February 1, 2009

Primary Completion

May 1, 2011

Study Completion

December 1, 2011

Last Updated

February 5, 2013

Record last verified: 2013-02

Locations