Genetic Basis of Hemangiomas - Full Text View

Sponsors and Collaborators:	Medical College of Wisconsin Children's Hospital and Health System Foundation, Wisconsin
Information provided by:	Medical College of Wisconsin
ClinicalTrials.gov Identifier:	NCT00466375

Purpose

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	Intervention
Hemangioma, Vascular Anomalies	Genetic: Cheek cell samples or blood sample (4mL) Genetic: Cheek cell sample or blood sample (4mL)

U.S. FDA Resources

Study Type:	Observational
Study Design:	Family-Based
Official Title:	Genetic Basis of Hemangiomas

Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:

SNP [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

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

Estimated Enrollment:	3000
Study Start Date:	April 2007
Estimated Study Completion Date:	May 2009

Groups/Cohorts	Assigned Interventions
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.

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:

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.
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.

Eligibility

Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466375

Contacts

Contact: Amy E Heinrich, RN	414-456-5769	aheinric@mcw.edu
Contact: Beth Drolet, MD	414-266-1569	bdrolet@mcw.edu

Locations

United States, Wisconsin
Children's Hospital of Wisconsin	Recruiting
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

Responsible Party:	Medical College of Wisconsin ( Beth Drolet, MD )
Study ID Numbers:	Genetics of Hemangioma
Study First Received:	April 25, 2007
Last Updated:	December 31, 2008
ClinicalTrials.gov Identifier:	NCT00466375
Health Authority:	United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:

hemangioma
vascular anomaly
infantile hemangioma

Study placed in the following topic categories:

Cardiovascular Abnormalities
Hemangioma, Capillary
Vascular Malformations
Hemangioma
Congenital Abnormalities

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009