Abnormality Clinical Trial
Official title:
Vascular Malformations and Abnormalities of Growth
To take part in this study you/your child have a vascular malformation, a type of blood
vessel disorder whose cause is unknown.
The investigators will do this by looking at changes in the genes and proteins in the cells
of the malformation as well as normal cells.
The investigators are doing this research because currently there is no known cause of
vascular malformations and no way to know whether or not other health problems will occur in
addition to the malformation. Through this research we hope to create standard methods for
doctors to examine and treat people with vascular anomalies.
If you/your child agree to participate
1. Informed consent and permission to use or disclose you/your child's health information
for reserve purposes will be obtained by the research team. You will receive a copy of
the consent form.
2. You/your child will be examined by a physician from the research team and interviewed
about your medical background and condition every year for five years.
3. You/your child will have photographs taken of the affected area at each visit.
4. You/your child will have two, one time biopsies or skin samples taken by a
dermatologist. Skin areas will be numbed with lidocaine and a 4 or 5 millimeter (or
approximately 0.15 to 0.19 inch) sample will be taken in two different locations. The
dermatologist taking the skin sample will use every effort to choose an area that can
be covered by clothing or kept out of sight to others. The doctor will either use
gelfoam or one stitch/suture per biopsy to seal off the area, which helps with healing
and preventing bleeding. If a stitch is placed in the biopsy site, another visit about
7-10 days following the procedure will be necessary to remove the stitch.
5. You may still participate in the study if you consent to having only one biopsy taken of
your affected (lesion) skin and not one of your unaffected (normal) skin.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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