Clinical trial NCT02471352: Studies of Dermatologic Diseases Biospecimen Acquisition Protocol
Official title: Studies of Dermatologic Diseases-Biospecimen Acquisition Protocol
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dermatologic Conditions
Healthy Volunteers
Normal Volunteers
Carcinoma, Merkel Cell
Keywords: Dermatologic Condition
Skin Disease
Biospecimen
Healthy Volunteers
Merkel Cell Carcinoma
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2015-06-15
Enrollment: 700
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Referrals of eligible subjects currently undergoing evaluation and/or treatment at the NIH Clinical Center

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.

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.

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.

Primary outcomes:
measure: Procure biologic samples for exploratory cellular, molecular, genetic and genomic biological studies
timeFrame: Time of collection
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: Heidi H Kong, M.D.
role: PRINCIPAL_INVESTIGATOR
References: