Studies of Dermatologic Diseases-Biospecimen Acquisition Protocol

  • STATUS
    Recruiting
  • End date
    Jan 31, 2027
  • participants needed
    500
  • sponsor
    National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Updated on 27 October 2022
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Accepts healthy volunteers

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.

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 of 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 500 consented subjects planned over 10 years.

Details
Condition Dermatologic Conditions, Healthy Volunteers, Normal Volunteers, Carcinoma, Merkel Cell
Clinical Study IdentifierNCT02471352
SponsorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Last Modified on27 October 2022

Eligibility

Yes No Not Sure

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
Ability of subject or Parents/guardian to understand and the willingness to sign a written informed consent document

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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