Studi di malattie dermatologiche Protocollo di acquisizione di campioni biologici
Studi sul protocollo di acquisizione di malattie dermatologiche-biospecimen
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.
Panoramica dello studio
Stato
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Heidi H Kong, M.D.
- Numero di telefono: (301) 827-2460
- Email: NIAMSderm@nih.gov
Luoghi di studio
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Maryland
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Bethesda, Maryland, Stati Uniti, 20892
- Reclutamento
- National Institutes of Health Clinical Center
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Contatto:
- Office of Patient Recruitment (OPR)
- Numero di telefono: 800-411-2222
- Email: ccopr@nih.gov
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Referrals of eligible subjects currently undergoing evaluation and/or treatment at the NIH Clinical Center
Descrizione
-
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Coorti e interventi
Gruppo / Coorte |
|---|
|
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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Procure biologic samples for exploratory cellular, molecular, genetic and genomic biological studies
Lasso di tempo: Time of collection
|
Collection of biologic samples |
Time of collection
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Heidi H Kong, M.D., National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stimato)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Neoplasie
- Infezioni
- Malattie virali
- Neoplasie per tipo istologico
- Neoplasie, ghiandolari ed epiteliali
- Adenocarcinoma
- Infezioni da virus del DNA
- Carcinoma
- Tumori neuroectodermici
- Neoplasie, cellule germinali ed embrionali
- Neoplasie, tessuto nervoso
- Tumori neuroendocrini
- Infezioni da virus tumorali
- Infezioni da poliomavirus
- Carcinoma, neuroendocrino
- Malattie della pelle e del tessuto connettivo
- Malattie della pelle
- Carcinoma, cellule di Merkel
Altri numeri di identificazione dello studio
- 150144
- 15-AR-0144
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Protocol is silent on sharing IPD.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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