Studies of Dermatologic Diseases Biospecimen Acquisition Protocol
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies, Skin and Soft Tissue Infections |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Other |
| Healthy: | No |
| Age Range: | 2 - 99 |
| Updated: | 3/28/2019 |
| Start Date: | June 19, 2015 |
| End Date: | January 31, 2027 |
| Contact: | Bryan P Higgins, R.N. |
| Email: | bryan.higgins@nih.gov |
| Phone: | (301) 402-6225 |
Studies of Dermatologic Diseases-Biospecimen Acquisition Protocol
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.
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 for 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 for 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.
- INCLUSION CRITERIA:
- Eligible participants must:
- Have a dermatologic condition, as determined by the PI or AIs, OR be at risk for
developing a dermatologic condition, as determined by the PI or AIs, OR be a
family member of a person with a dermatologic condition OR be a healthy
volunteer, as defined as a person with no known significant health problems.
- Be willing to provide biospecimens for research and clinical studies, and for
storage to be used for future research.
- Subjects of age greater than or equal to 2 years old are eligible.
- Ability of subject or Legally Authorized Representative to understand and the
willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
- Presence of conditions that, in the judgment of the investigator, may put the subject
at undue risk or make them unsuitable for participation in the study.
- Inability to comply with the requirements of the protocol.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 888-624-1937
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