Vascular Malformations and Abnormalities of Growth

Abnormality Clinical Trial

Official title:

Vascular Malformations and Abnormalities of Growth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01105676
• Other study ID #: CHW 08/204, GC 821
• Status: Completed
• Phase: N/A
• First received: April 15, 2010
• Last updated: January 6, 2014
• Start date: November 2008
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Abnormality
• Congenital Abnormalities
• Vascular Malformations

Intervention

Procedure:
• skin biopsy
Two skin biopsies will be taken one time

Locations

Country	Name	City	State
United States	Childrens Hospital of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Children's Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of growth over time		5 years	No
Secondary	Patient specific gene and protein expression levels that can distinguish affected from unaffected tissue in patients.		5 years	No