Études sur les maladies dermatologiques Protocole d'acquisition d'échantillons biologiques
Études des maladies dermatologiques - Protocole d'acquisition d'échantillons biologiques
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.
Aperçu de l'étude
Statut
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Heidi H Kong, M.D.
- Numéro de téléphone: (301) 827-2460
- E-mail: NIAMSderm@nih.gov
Lieux d'étude
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Maryland
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Bethesda, Maryland, États-Unis, 20892
- Recrutement
- National Institutes of Health Clinical Center
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Contact:
- Office of Patient Recruitment (OPR)
- Numéro de téléphone: 800-411-2222
- E-mail: ccopr@nih.gov
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Referrals of eligible subjects currently undergoing evaluation and/or treatment at the NIH Clinical Center
La description
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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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / 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 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Procure biologic samples for exploratory cellular, molecular, genetic and genomic biological studies
Délai: Time of collection
|
Collection of biologic samples |
Time of collection
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Heidi H Kong, M.D., National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimé)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Tumeurs
- Infections
- Maladies virales
- Tumeurs par type histologique
- Tumeurs, glandulaires et épithéliales
- Adénocarcinome
- Infections par le virus de l'ADN
- Carcinome
- Tumeurs neuroectodermiques
- Tumeurs, cellules germinales et embryonnaires
- Tumeurs, tissu nerveux
- Tumeurs neuroendocrines
- Infections virales tumorales
- Infections à polyomavirus
- Carcinome neuroendocrinien
- Maladies de la peau et du tissu conjonctif
- Maladies de la peau
- Carcinome, cellule de Merkel
Autres numéros d'identification d'étude
- 150144
- 15-AR-0144
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Protocol is silent on sharing IPD.
Informations sur les médicaments et les dispositifs, documents d'étude
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