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NCT Number: NCT02471352

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.

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Key information

Conditions

Dermatologic Conditions Adenocarcinoma Carcinoma Carcinoma, Merkel Cell Carcinoma, Neuroendocrine DNA Virus Infections Healthy Volunteers Infections Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Normal Volunteers Polyomavirus Infections Skin Diseases Skin and Connective Tissue Diseases Tumor Virus Infections Virus Diseases

Age range

1 day–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location status: Recruiting

Location contact

Office of Patient Recruitment (OPR)

CONTACT

[email protected]

800-411-2222

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Procure biologic samples for exploratory cellular, molecular, genetic and genomic biological studies

Time frame: Time of collection

Collection of biologic samples

Study contacts

Contact information is provided by the study sponsor or research team.

Heidi H Kong, M.D.

CONTACT

[email protected]

(301) 827-2460

Sponsors and collaborators

Lead sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Nih

Registry information

Official study title

Studies of Dermatologic Diseases-Biospecimen Acquisition Protocol

Important dates

Study start: 2015
Primary completion: 2027
Study completion: 2027
First posted: Jun 15, 2015
Registry last updated: May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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