Genetic Basis of Hemangiomas

NCT ID: NCT00466375

Last Updated: 2017-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Study Completion Date

2016-05-31

Brief Summary

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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

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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.

Conditions

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Hemangioma, Vascular Anomalies

Study Design

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Observational Model Type

FAMILY_BASED

Study Time Perspective

OTHER

Study Groups

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A

Patients with a hemangioma.

Cheek cell samples or blood sample (4mL)

Intervention Type GENETIC

DNA will be extracted from cheek cell or blood samples from parents and child having hemangioma.

B.

Patients with a vascular anomaly.

Cheek cell sample or blood sample (4mL)

Intervention Type GENETIC

DNA will be extracted from cheek cell or blood samples of parents and child with a vascular anomaly.

Interventions

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Cheek cell samples or blood sample (4mL)

DNA will be extracted from cheek cell or blood samples from parents and child having hemangioma.

Intervention Type 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.

Intervention Type GENETIC

Eligibility Criteria

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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.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital and Health System Foundation, Wisconsin

OTHER

Sponsor Role collaborator

Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

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Beth A Drolet, MD

Professor and Vice Chairman of Pediatric Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Beth Drolet, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

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Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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Genetics of Hemangioma

Identifier Type: -

Identifier Source: org_study_id

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