Vascular Malformations and Abnormalities of Growth

NCT01105676 | Completed

• 1 other identifier: CHW 08/204, GC 821
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Abnormality

Keywords

vascular malformation; vascular anomalies; abnormalities of growth; overgrowth; subjects with vascular malformations abnormalities of growth.

Outcome Measures

Primary Outcomes (1)

• Percent of growth over time

  5 years

Secondary Outcomes (1)

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

  5 years

Study Arms (1)

single group single arm study

EXPERIMENTAL

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

Procedure: skin biopsy

Interventions

skin biopsy PROCEDURE

Two skin biopsies will be taken one time

single group single arm study

Eligibility Criteria

• Age: 12 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Children's National Research Institute: collaborator

Study Sites (1)

Childrens Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Congenital Abnormalities; Vascular Malformations

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cardiovascular Abnormalities; Cardiovascular Diseases

Study Officials

• Kelly Duffy, MD

  Children's Hospital and Health System Foundation, Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Vice Chairman of Pediatric Dermatology

Study Record Dates

• First Submitted: April 15, 2010
• First Posted: April 16, 2010
• Study Start: November 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 7, 2014

Record last verified: 2014-01

Locations

US (1)