Genetic Basis of Hemangiomas

Terminated

• Conditions: Hemangioma, Vascular Anomalies
• Interventions: Genetic: Cheek cell samples or blood sample (4mL); Genetic: Cheek cell sample or blood sample (4mL)

• Registration Number: NCT00466375
• Lead Sponsor: Medical College of Wisconsin

Brief Summary

The purpose of this study is to determine if there are genes that are common in children with infantile hemangioma. This information will allow physicians to improve care for patients who have been diagnosed with this disease and to provide their parents with more complete information regarding the cause of this disease. This research is being done because many unanswered questions remain regarding children with infantile hemangioma. There are very few medications to treat infants with hemangiomas.

Detailed Description

WHAT IS INVOLVED IN THE RESEARCH STUDY?

* Buccal smear (cheek cells) or small blood sample (4 mL or 1 teaspoon) from child being seen in the Dermatology clinic having infantile hemangioma or vascular anomaly

* Buccal smear (cheek cells) or small blood sample (4 mL or 1 teaspoon) from parents of child

If you and your child agree to be in this study, the following will happen:

1. Informed consent and permission to use or disclose your/your child's health information for research purposes will be obtained by Dr. Drolet, the principal investigator, or her research team. You will receive a copy of this consent form.

2. A buccal swab or blood sample will be obtained from you and your child; buccal sampling involves rubbing the inside of your cheek and removing cells to perform a genetic test called "Genomewide Association (GWA).

We expect you and your child to be involved in this study until you and your child have the genetic testing performed.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-04-25
• Study First Submitted QC: 2007-04-25
• Study First Posted: 2007-04-27
• Primary Completion: 2014-11
• Study Completion: 2016-05
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-28
• Last Update Posted: 2017-08-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• No limit to age
• Diagnosis of infantile hemangioma and/or vascular anomaly
• Unaffected twin sibling
• Each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent. Each patient must also give assent to study participation.

Study Population

Exclusion Criteria

• Diagnosis other than infantile hemangioma or vascular anomaly
• If the lesion has resolved and cannot be confirmed as a hemangioma by clinical exam
• If the biologic parents are unwilling or unable to submit DNA samples the child will be excluded from the DNA study. Therefore, if DNA samples cannot be or are not obtained from both biologic parents, the child and family will be excluded from the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	Cheek cell samples or blood sample (4mL)	Patients with a hemangioma.
B.	Cheek cell sample or blood sample (4mL)	Patients with a vascular anomaly.

Primary Outcome Measures

Name	Time	Method
SNP	3 years

Trial Locations

Locations (1)

Children's Hospital of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States