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Protocol Details

Studies of Dermatologic Diseases-Biospecimen Acquisition Protocol

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

15-AR-0144

Sponsoring Institute

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

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 1 days
Max Age: 100 Years

Referral Letter Required

No

Population Exclusion(s)

Adults who are or may become unable to consent

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

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

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Arthritis and Musculoskeletal and Skin Diseases

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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Eligibility

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 or equal to 2 years old 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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Heidi H. Kong, M.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)



Monica Taylor, R.N.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institutes of Health
Building 10
Room 13C429A
10 Center Drive
Bethesda, Maryland 20892
(301) 451-2221
monica.taylor@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT02471352

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