Studies of Dermatologic Diseases Biospecimen Acquisition Protocol

Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT02471352
Collaborator
(none)
500
Enrollment
1
Location
139.4
Anticipated Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

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 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.

Study Design

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

Arms and Interventions

ArmIntervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Procure biologic samples for exploratory cellular, molecular, genetic and genomic biological studies [Time of collection]

    Collection of biologic samples

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
  • 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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1National Institutes of Health Clinical Center, 9000 Rockville PikeBethesdaMarylandUnited States20892

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
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:
Jun 15, 2015
Last Update Posted:
Nov 16, 2021
Last Verified:
Nov 12, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 16, 2021