Vascular Malformations and Abnormalities of Growth | NCT01105676

Studies
Vascular Malformations and Abnormalities of Growth

NCT01105676

Sponsor

Medical College of Wisconsin

Status

Completed

Last Update Posted

Jan 7, 2014Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Abnormality

Interventions

skin biopsy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Apr 15, 2010

First Submission Date that Met QC Criteria

Apr 15, 2010

First Posted Date

Apr 16, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2014

Last Update Posted Date

Jan 7, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Beth Drolet, Professor and Vice Chairman of Pediatric Dermatology, Medical College of WisconsinPrincipal Investigator

Lead Sponsor

Medical College of WisconsinOTHER

Collaborators

Name	Class
Children's National Research Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
single group single arm study	Experimental	Open no masking is used. All involved know the identity of the intervention assignment	Procedure: skin biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
skin biopsy	Procedure	Two skin biopsies will be taken one time	single group single arm study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent of growth over time		5 years

Secondary Outcomes

Measure	Description	Time Frame
Patient specific gene and protein expression levels that can distinguish affected from unaffected tissue in patients.		5 years

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Months

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kelly Duffy, MD	Children's Hospital and Health System Foundation, Wisconsin	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Childrens Hospital of Wisconsin		Milwaukee	Wisconsin	53226	United States

Condition Browse Module

MeSH Terms

ID	Term
D000013	Congenital Abnormalities
D054079	Vascular Malformations

Ancestor Terms

ID	Term
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases

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Browse Branches

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