Studies of Dermatologic Diseases-Biospecimen Acquisition Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Procure biologic samples for exploratory cellular, molecular, genetic and genomic biological studies
研究概览
简要总结
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:
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People ages 2 and older who have:
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A skin disease or at risk of developing a skin disease OR
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A family member of persons with a skin disease
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Healthy volunteers ages 2 and older
Design:
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Participants will be screened under a separate protocol.
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Participants may take a survey about how their skin condition affects their quality of life.
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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.
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Participants will have specimens collected. This may include:
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Several teaspoons of blood taken at each visit
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Stool samples
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Nail and body fluid (like saliva) samples
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Cheek swabs. The inside of the cheek will be scraped for about a minute in each direction to collect cells.
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Collection of skin samples with:
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A swab (like a Q-tip)
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Gently scraping skin to remove the outer layers of cells
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Applying and removing 1-inch pieces of tape
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Participants may have up to 4 skin biopsies in 12 months, with 4 separate biopsies taken each time.
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An area of skin will be numbed with an injection.
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A piece of skin the size of a pencil eraser will be removed using a small instrument.
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A flat scar usually develops at the biopsy site.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 0 years old (including only viable neonates) are eligible.
排除标准
- •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.
研究组 & 干预措施
1/ Skin disease or at risk
Subjects with a skin disease or at risk of developing a skin disease/ Family member of persons with a skin disease
2/ Healthy Volunteers
Healthy Volunteers
结局指标
主要结局
Procure biologic samples for exploratory cellular, molecular, genetic and genomic biological studies
时间窗: Time of collection
Collection of biologic samples
次要结局
未报告次要终点