Genetic Basis of Hemangiomas

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment
Hemangioma, Vascular Anomalies	Genetic: Cheek cell samples or blood sample (4mL); Genetic: Cheek cell sample or blood sample (4mL)

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 Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	300 participants
Observational Model:	Family-Based
Time Perspective:	Other
Official Title:	Genetic Basis of Hemangiomas
Study Start Date :	April 2007
Actual Primary Completion Date :	November 2014
Actual Study Completion Date :	May 2016

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
A; Patients with a hemangioma.	Genetic: Cheek cell samples or blood sample (4mL); DNA will be extracted from cheek cell or blood samples from parents and child having hemangioma.
B.; Patients with a vascular anomaly.	Genetic: Cheek cell sample or blood sample (4mL); DNA will be extracted from cheek cell or blood samples of parents and child with a vascular anomaly.

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. SNP [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA

Buccal smear (cheek cells)or small blood sample (4 mL or one teaspoon)

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Clinics from Children's Hospital of Wisconsin.

Criteria

Study Population 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.

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

Medical College of Wisconsin

Children's Hospital and Health System Foundation, Wisconsin

Investigators

Principal Investigator:	Beth Drolet, MD	Medical College of Wisconsin

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Beth A Drolet, MD, Professor and Vice Chairman of Pediatric Dermatology, Medical College of Wisconsin
ClinicalTrials.gov Identifier:	NCT00466375 History of Changes
Other Study ID Numbers:	Genetics of Hemangioma
First Posted:	April 27, 2007
Last Update Posted:	August 29, 2017
Last Verified:	August 2017

Keywords provided by Beth A Drolet, MD, Medical College of Wisconsin:

hemangioma; vascular anomaly; infantile hemangioma

Additional relevant MeSH terms:

Congenital Abnormalities; Hemangioma; Vascular Malformations; Neoplasms, Vascular Tissue	Neoplasms by Histologic Type; Neoplasms; Cardiovascular Abnormalities; Cardiovascular Diseases