Ignite Creation Date:
2024-05-06 @ 7:08 AM
Last Modification Date:
2024-10-26 @ 11:44 AM
Study NCT ID:
NCT02471352
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2015-06-12
Brief Title:
Studies of Dermatologic Diseases Biospecimen Acquisition Protocol
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Studies of Dermatologic Diseases-Biospecimen Acquisition Protocol
Status:
RECRUITING
Status Verified Date:
2024-10-07
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:
Background
- Skin disease can have many causes It can have widespread consequences and in rare cases can lead to death Researchers want to determine the causes of various types of skin diseases and find a way to treat them
Objectives
- To determine the causes of various skin diseases and find ways to treat them
Eligibility
People ages 2 and older who have
A skin disease or at risk of developing a skin disease OR
A family member of persons with a skin disease
Healthy volunteers ages 2 and older
Design
Participants will be screened under a separate protocol
Participants may take a survey about how their skin condition affects their quality of life
Participants will have a medical history and a physical exam including a detailed skin exam Pictures will be taken of their skin to document any skin disease
Participants will have specimens collected This may include
Several teaspoons of blood taken at each visit
Stool samples
Nail and body fluid like saliva samples
Cheek swabs The inside of the cheek will be scraped for about a minute in each direction to collect cells
Collection of skin samples with
A swab like a Q-tip
Gently scraping skin to remove the outer layers of cells
Applying and removing 1-inch pieces of tape
Participants may have up to 4 skin biopsies in 12 months with 4 separate biopsies taken each time
An area of skin will be numbed with an injection
A piece of skin the size of a pencil eraser will be removed using a small instrument
A flat scar usually develops at the biopsy site
- Skin disease can have many causes It can have widespread consequences and in rare cases can lead to death Researchers want to determine the causes of various types of skin diseases and find a way to treat them
Objectives
- To determine the causes of various skin diseases and find ways to treat them
Eligibility
People ages 2 and older who have
A skin disease or at risk of developing a skin disease OR
A family member of persons with a skin disease
Healthy volunteers ages 2 and older
Design
Participants will be screened under a separate protocol
Participants may take a survey about how their skin condition affects their quality of life
Participants will have a medical history and a physical exam including a detailed skin exam Pictures will be taken of their skin to document any skin disease
Participants will have specimens collected This may include
Several teaspoons of blood taken at each visit
Stool samples
Nail and body fluid like saliva samples
Cheek swabs The inside of the cheek will be scraped for about a minute in each direction to collect cells
Collection of skin samples with
A swab like a Q-tip
Gently scraping skin to remove the outer layers of cells
Applying and removing 1-inch pieces of tape
Participants may have up to 4 skin biopsies in 12 months with 4 separate biopsies taken each time
An area of skin will be numbed with an injection
A piece of skin the size of a pencil eraser will be removed using a small instrument
A flat scar usually develops at the biopsy site
Detailed Description:
Background
Skin diseases represent one of the most common medical problems in the United States affecting 1 in 3 people at any given time
Complex interactions between genetic background and the environment are relevant to understanding skin disease
By studying dermatoses we may gain insight into the complex host-environment interactions that give rise to or exacerbate these skin conditions and into links between inflammation and cancer
Objective
-To procure biologic samples for exploratory cellular molecular genetic and genomic biological studies from subjects with dermatologic conditions subjects at risk for developing dermatologic conditions and healthy volunteers in the support of NIH biomedical studies
Eligibility
-Subjects with or at risk of developing dermatologic diseases family members of subjects with dermatologic diseases or healthy volunteers including adults and children
Design
The purpose of this study is to examine in an exploratory fashion a variety of biologic assays relevant to the investigation of dermatologic diseases
Approximately 50 subjects are anticipated to consent to the study each year with an accrual ceiling of 500 consented subjects planned over 10 years
Skin diseases represent one of the most common medical problems in the United States affecting 1 in 3 people at any given time
Complex interactions between genetic background and the environment are relevant to understanding skin disease
By studying dermatoses we may gain insight into the complex host-environment interactions that give rise to or exacerbate these skin conditions and into links between inflammation and cancer
Objective
-To procure biologic samples for exploratory cellular molecular genetic and genomic biological studies from subjects with dermatologic conditions subjects at risk for developing dermatologic conditions and healthy volunteers in the support of NIH biomedical studies
Eligibility
-Subjects with or at risk of developing dermatologic diseases family members of subjects with dermatologic diseases or healthy volunteers including adults and children
Design
The purpose of this study is to examine in an exploratory fashion a variety of biologic assays relevant to the investigation of dermatologic diseases
Approximately 50 subjects are anticipated to consent to the study each year with an accrual ceiling of 500 consented subjects planned over 10 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 15-AR-0144 | None | None | None |