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OpenTrials
Completed

NCT Number: NCT01105676

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.

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Key information

Age range

12 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Childrens Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

About this study

If you/your child agree to participate

  • 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.
  • 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.
  • You/your child will have photographs taken of the affected area at each visit.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Greater than 1 year of age
  • Diagnosis of vascular malformation
  • 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 given they have the cognitive capacity to do so.

Exclusion criteria

  • Patients less than 1 year of age
  • Vascular malformations likely to result in poor wound healing or located in areas of the body prone to significant scarring
  • Individuals with vascular malformations and previous diagnosis of disseminated intravascular coagulopathy

Treatment and study plan

skin biopsy

Procedure

Two skin biopsies will be taken one time

Primary outcomes

  1. Percent of growth over time

    Time frame: 5 years

Secondary outcomes

  1. Patient specific gene and protein expression levels that can distinguish affected from unaffected tissue in patients.

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • Children's National Research Institute

Registry information

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Apr 16, 2010
Registry last updated
Jan 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.