Studies of Dermatologic Diseases Biospecimen Acquisition Protocol

NCT02471352 | Recruiting

• 2 other identifiers: 15014415-AR-0144
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dermatologic Conditions; Healthy Volunteers; Normal Volunteers; Carcinoma, Merkel Cell

Keywords

Dermatologic Condition; Skin Disease; Biospecimen; Healthy Volunteers; Merkel Cell Carcinoma; Natural History

Outcome Measures

Primary Outcomes (1)

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

  Collection of biologic samples

  Time of collection

Study Arms (2)

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

Eligibility Criteria

• Age: 1 Day - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Referrals of eligible subjects currently undergoing evaluation and/or treatment at the NIH Clinical Center

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (1)

• 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 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Carcinoma, Merkel Cell; Skin Diseases

Condition Hierarchy (Ancestors)

Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Skin and Connective Tissue Diseases

Study Officials

• Heidi H Kong, M.D.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heidi H Kong, M.D.

CONTACT

(301) 827-2460; NIAMSderm@nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2015
• First Posted: June 15, 2015
• Study Start: June 19, 2015
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03-09

Locations

US (1)