Estudios de enfermedades dermatológicas Protocolo de adquisición de muestras biológicas
Estudios de Enfermedades Dermatológicas-Protocolo de Adquisición de Bioespecímenes
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:
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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
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Healthy volunteers ages 2 and older
Design:
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Participants will be screened under a separate protocol.
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Participants may take a survey about how their skin condition affects their quality of life.
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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.
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Participants will have specimens collected. This may include:
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Several teaspoons of blood taken at each visit
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Stool samples
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Nail and body fluid (like saliva) samples
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Cheek swabs. The inside of the cheek will be scraped for about a minute in each direction to collect cells.
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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
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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.
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Heidi H Kong, M.D.
- Número de teléfono: (301) 827-2460
- Correo electrónico: NIAMSderm@nih.gov
Ubicaciones de estudio
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Maryland
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Bethesda, Maryland, Estados Unidos, 20892
- Reclutamiento
- National Institutes of Health Clinical Center
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Contacto:
- Office of Patient Recruitment (OPR)
- Número de teléfono: 800-411-2222
- Correo electrónico: ccopr@nih.gov
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Referrals of eligible subjects currently undergoing evaluation and/or treatment at the NIH Clinical Center
Descripción
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INCLUSION CRITERIA:
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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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
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 |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Procure biologic samples for exploratory cellular, molecular, genetic and genomic biological studies
Periodo de tiempo: Time of collection
|
Collection of biologic samples |
Time of collection
|
Colaboradores e Investigadores
Investigadores
- Investigador principal: Heidi H Kong, M.D., National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimado)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias
- Infecciones
- Enfermedades virales
- Neoplasias por tipo histológico
- Neoplasias Glandulares y Epiteliales
- Adenocarcinoma
- Infecciones por virus de ADN
- Carcinoma
- Tumores neuroectodérmicos
- Neoplasias De Células Germinales Y Embrionarias
- Neoplasias De Tejido Nervioso
- Tumores neuroendocrinos
- Infecciones por virus tumorales
- Infecciones por poliomavirus
- Carcinoma Neuroendocrino
- Enfermedades de la piel y del tejido conectivo
- Enfermedades de la piel
- Carcinoma De Células De Merkel
Otros números de identificación del estudio
- 150144
- 15-AR-0144
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Protocol is silent on sharing IPD.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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