Studies of Dermatologic Diseases Biospecimen Acquisition Protocol
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Dermatologic Conditions, Healthy Volunteers, Normal Volunteers, Carcinoma, Merkel Cell. Basic parameters: 1 Day — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Studies of Dermatologic Diseases-Biospecimen Acquisition Protocol
Overview
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.
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 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 700 consented subjects planned over 10 years.
Primary outcome measures
- Procure biologic samples for exploratory cellular, molecular, genetic and genomic biological studies [Time frame: Time of collection]
Eligibility criteria
- 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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- National Institutes of Health Clinical Center — Bethesda
Publications
- Ahmed N, Joglekar P, Deming C; NISC Comparative Sequencing Program; Lemon KP, Kong HH, Segre JA, Conlan S. Genomic characterization of the C. tuberculostearicum species complex, a prominent member of the human skin microbiome. mSystems. 2023 Dec 21;8(6):e0063223. doi: 10.1128/msystems.00632-23. Epub 2023 Nov 10. PMID 38126779
Identifiers
NCT: NCT02471352 · 150144 · 15-AR-0144