Vascular Malformations and Abnormalities of Growth

NCT ID: NCT01105676

Last Updated: 2014-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2013-12-31

Brief 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.

Detailed 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.

Conditions

Abnormality

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

single group single arm study

Open no masking is used. All involved know the identity of the intervention assignment

Group Type: EXPERIMENTAL

skin biopsy

Intervention Type: PROCEDURE

Two skin biopsies will be taken one time

Interventions

skin biopsy

Two skin biopsies will be taken one time

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's National Research Institute

OTHER

Sponsor Role: collaborator

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Beth Drolet

Professor and Vice Chairman of Pediatric Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kelly Duffy, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital and Health System Foundation, Wisconsin

Locations

Childrens Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

CHW 08/204, GC 821

Identifier Type: -

Identifier Source: org_study_id