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Genetic Basis of Hemangiomas

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Children's Hospital and Health System Foundation, Wisconsin
Information provided by (Responsible Party):
Beth Drolet, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00466375
First received: April 25, 2007
Last updated: March 16, 2016
Last verified: March 2016
History of Changes
  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)

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

Resource links provided by NLM:

MedlinePlus related topics: Birthmarks
U.S. FDA Resources

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
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 2017
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
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:

  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.

  Eligibility
Ages Eligible for Study:   Child, Adult, Senior
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Responsible Party: Beth Drolet, 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 
Study First Received: April 25, 2007
Last Updated: March 16, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on September 27, 2016