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Studies of Dermatologic Diseases Biospecimen Acquisition Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02471352
Recruitment Status : Recruiting
First Posted : June 15, 2015
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) )

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.

Condition or disease
Dermatologic Conditions Healthy Volunteers Normal Volunteers Carcinoma, Merkel Cell

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 500 consented subjects planned over 10 years.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Studies of Dermatologic Diseases-Biospecimen Acquisition Protocol
Actual Study Start Date : June 19, 2015
Estimated Primary Completion Date : January 1, 2026
Estimated Study Completion Date : January 31, 2027


Group/Cohort
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



Primary Outcome Measures :
  1. Procure biologic samples for exploratory cellular, molecular, genetic and genomic biological studies [ Time Frame: Time of collection ]
    Collection of biologic samples



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Referrals of eligible subjects currently undergoing evaluation and/or treatment at the NIH Clinical Center
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471352


Contacts
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Contact: Glenna Banania (301) 402-6225 glenna.banania@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
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Principal Investigator: Heidi H Kong, M.D. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Additional Information:
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Responsible Party: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier: NCT02471352    
Other Study ID Numbers: 150144
15-AR-0144
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 22, 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ):
Dermatologic Condition
Skin Disease
Biospecimen
Healthy Volunteers
Merkel Cell Carcinoma
Additional relevant MeSH terms:
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Carcinoma, Merkel Cell
Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Polyomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Carcinoma, Neuroendocrine
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue