Studies of Dermatologic Diseases-Biospecimen Acquisition Protocol
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- STATUS
- Recruiting
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- End date
- Jan 31, 2027
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- participants needed
- 500
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- sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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.
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
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- 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.
Details
| Condition | Dermatologic Conditions, Healthy Volunteers, Normal Volunteers, Carcinoma, Merkel Cell |
|---|---|
| Clinical Study Identifier | NCT02471352 |
| Sponsor | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
| Last Modified on | 27 October 2022 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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