Vascular Malformations and Abnormalities of Growth

This study has been completed.
Sponsor:
Collaborator:
Children's Research Institute
Information provided by (Responsible Party):
Beth Drolet, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01105676
First received: April 15, 2010
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Abnormality
Procedure: skin biopsy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Vascular Malformations and Abnormalities of Growth

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Percent of growth over time [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient specific gene and protein expression levels that can distinguish affected from unaffected tissue in patients. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: November 2008
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single group single arm study
Open no masking is used. All involved know the identity of the intervention assignment
Procedure: skin biopsy
Two skin biopsies will be taken one time

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.

  Eligibility

Ages Eligible for Study:   12 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01105676

Locations
United States, Wisconsin
Childrens Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Children's Research Institute
Investigators
Principal Investigator: Kelly Duffy, MD Children's Hospital and Health System Foundation, Wisconsin
  More Information

No publications provided

Responsible Party: Beth Drolet, Professor and Vice Chairman of Pediatric Dermatology, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01105676     History of Changes
Other Study ID Numbers: CHW 08/204, GC 821
Study First Received: April 15, 2010
Last Updated: January 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
vascular malformation
vascular anomalies
abnormalities of growth
overgrowth
subjects with vascular malformations abnormalities of growth.

Additional relevant MeSH terms:
Congenital Abnormalities
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 01, 2014