Ignite Creation Date:
2024-05-05 @ 10:25 PM
Last Modification Date:
2024-10-26 @ 10:18 AM
Study NCT ID:
NCT01105676
Status:
COMPLETED
Last Update Posted:
2014-01-07
First Post:
2010-04-15
Brief Title:
Vascular Malformations and Abnormalities of Growth
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
Vascular Malformations and Abnormalities of Growth
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To take part in this study youyour 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
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 youyour child agree to participate
1 Informed consent and permission to use or disclose youyour childs health information for reserve purposes will be obtained by the research team You will receive a copy of the consent form
2 Youyour 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 Youyour child will have photographs taken of the affected area at each visit
4 Youyour 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 015 to 019 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 stitchsuture 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
1 Informed consent and permission to use or disclose youyour childs health information for reserve purposes will be obtained by the research team You will receive a copy of the consent form
2 Youyour 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 Youyour child will have photographs taken of the affected area at each visit
4 Youyour 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 015 to 019 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 stitchsuture 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None