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Genetic Basis of Hemangiomas

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ClinicalTrials.gov Identifier: NCT00466375
Recruitment Status : Terminated
First Posted : April 27, 2007
Last Update Posted : August 29, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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

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
Primary Completion Date : November 2014
Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birthmarks
U.S. FDA Resources

Groups and Cohorts

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 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    Key Record Dates
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