- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04888923
Histoire naturelle de la réponse biologique humaine à l'exposition et aux blessures environnementales
Background:
Environmental exposures like pollution, diet, and stress can help cause human diseases, or make them worse. Researchers want to better understand how injury and inflammation are caused by these exposures. They want to collect biological and environmental samples and other data. They may use the samples to measure a range of factors, like hormones, toxins, and chemicals. This will help them improve their studies.
Objective:
To identify and understand how environmental exposures contribute to human disease.
Eligibility:
Healthy adults ages 18 and older
Design:
Participants will be screened with questions about their health history, demographics, and medicines they take.
Participants may give blood, hair, stool, saliva, and/or urine samples. They may have a skin punch biopsy to collect skin cells. They may give fingernail or toenail clippings. They may give a sample of exhaled breath.
Participants may give a sputum sample. They will inhale a saline mist and cough mucus into a cup.
Participants may have their nasal passages brushed, scraped, or washed.
Participants may give cheek cell samples. They will swish mouthwash and spit it into a cup.
Participants who produce sperm may give samples.
Participants may have bronchoscopy to collect fluid. A saline solution will be put into their lung and then suctioned out, washing areas of the lung.
Participants may have a pelvic or transvaginal ultrasound. They may have lung function tests.
Participants may collect household dust, urine, or stool at home.
Participants will complete surveys about their health, diet, and exposures.
Participation will last for one or more study visits.
Participants may be contacted in the future to take part in other studies.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Study Description:
Environmental exposures such as pollution, diet, stress, etc. contribute to the development and exacerbation of human disease. Understanding the mechanisms of environmentally induced injury and inflammation will allow us to devise better prophylaxis and treatment measures.
Subjects may undergo sampling of (including but not limited to:) blood, urine, saliva, household dust, cheek cells, hair, nasal cells, stool, nail clippings, exhaled breath condensate, sperm samples, skin cells, and/or sputum etc., and may answer predefined questionnaires regarding health and exposures.
Studies which may be performed on collected material includes establishment of cell cultures and immunologic studies.
Objectives:
Primary Objective: To identify the interaction of host and environmental factors in the response to injury and the development of disease.
Secondary Objectives: To develop better methodological tools in order to quantify host-environmental interactions in health and disease.
Endpoints:
Primary Endpoint: Biological markers of cell/tissue injury and inflammation, such as inflammatory cytokines, intracellular kinases or DNA/RNA damage in association with in vitro or in vivo environmental exposures.
Secondary Endpoints: Diseases or pathological processes (e.g. abnormal laboratory values) associated with environmental exposures.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: NIEHS Join A Study Recruitment Group
- Numéro de téléphone: (855) 696-4347
- E-mail: myniehs@nih.gov
Sauvegarde des contacts de l'étude
- Nom: Lawrence S Kirschner, M.D.
- Numéro de téléphone: (984) 287-3562
- E-mail: lawrence.kirschner@nih.gov
Lieux d'étude
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North Carolina
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Research Triangle Park, North Carolina, États-Unis, 27709
- Recrutement
- NIEHS Clinical Research Unit (CRU)
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Contact:
- NIEHS Join A Study Recruitment Group
- Numéro de téléphone: 855-696-4347
- E-mail: myniehs@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
The general community sample will be from Durham, Raleigh, Chapel Hill and other nearby cities close to the NIEHS Clinical Research Unit (CRU).
La description
- INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Ability to provide informed consent.
- Able to read and speak English
- Male or female, aged >=18
- Able to travel to the NIEHS CRU for study visits or travel to an offsite event or conference.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
- Not willing to have samples stored for future use.
- Current pregnancy or lactation, by participant verbal confirmation.
- Any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with required study procedures.
Participants will be enrolled according to pre-defined host (e.g. disease, genetic, or demographic) or environmental (exposure) characteristics.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: OTHER
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
|---|
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Healthy Controls
General public population, including females and males, who are over the age of 18, with a mixture of races and ethnicities representative of North Carolina. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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To identify the interaction of host and environmental factors in the response to injury and the development of disease.
Délai: On-going
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To identify the interaction of host and environmental factors in the response to injury and the development of disease. |
On-going
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Lawrence S Kirschner, M.D., National Institute of Environmental Health Sciences (NIEHS)
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 (Réel)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 10000152
- 000152-E
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Most of the participant data will be utilized by investigators in an aggregate way to validate or invalidate their research.
Informations sur les médicaments et les dispositifs, documents d'étude
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