Studies of Dermatologic Diseases Biospecimen Acquisition Protocol
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02471352|
Recruitment Status : Recruiting
First Posted : June 15, 2015
Last Update Posted : December 20, 2019
- 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.
- To determine the causes of various skin diseases and find ways to treat them.
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
- 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.
|Condition or disease|
|Dermatologic Conditions Healthy Volunteers Normal Volunteers Carcinoma, Merkel Cell|
- 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.
-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
-Subjects with or at risk for developing dermatologic diseases, family members of subjects with dermatologic diseases, or healthy volunteers, including adults and children.
- 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 Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Studies of Dermatologic Diseases-Biospecimen Acquisition Protocol|
|Actual Study Start Date :||June 19, 2015|
|Estimated Primary Completion Date :||January 1, 2026|
|Estimated Study Completion Date :||January 31, 2027|
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
- Procure biologic samples for exploratory cellular, molecular, genetic and genomic biological studies [ Time Frame: Time of collection ]Collection of biologic samples
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471352
|Contact: Valentina S Pillai, C.R.N.P.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Heidi H Kong, M.D.||National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)|