- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01386892
Immunological Characterization of Blood of Normal Individuals
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Blood will be obtained via peripheral venipuncture. The blood will be divided into components (e.g. plasma, serum, microvesicles, and cells) then analyzed. Flow cytometry will be used to determine cell and microvesicle subsets. RNA will be extracted from the various components of blood and will be subjected to gene and microRNA profiling to determine gene expression. DNA will be isolated from the cells to be used in studies investigating epigenetic regulation of genes identified in the screens. Protein will also be isolated from the multiple components to examine the impact of genetic regulation by epigenetic mechanisms or microRNA on protein expression. Peripheral blood mononuclear cells will be placed in tissue culture for study.
Saliva and urine will be obtained the same day as blood for testing.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
Ohio
-
Columbus, Ohio, États-Unis, 43210
- The Ohio State University
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Healthy with no chronic or acute illnesses, or taking medication which in the opinion of the PI would impact the analyses being conducted.
- At least 18 years or older.
- Are capable of reading, understanding and providing written informed consent.
Exclusion Criteria:
- Non-English speaking.
- Individuals under 18 years old.
- Woman who believe they are or may be pregnant. (Based on self reporting. Pregnancy testing will not be conducted for the purposes of this study)
- Individuals experiencing acute or chronic illnesses which in the opinion of the PI would impact the analyses being conducted.
- Currently taking prescription or over the counter medication which in the opinion of the PI would impact the analyses being conducted.
- Individual has donated blood more than twice in the last week or the amount to be drawn will exceed the maximum allowance in the last 8 weeks.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Healthy Volunteer
Healthy Volunteer without lung disease
|
Il n'y a pas d'intervention pour cette étude
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Blood content differences between the lung disease and healthy control populations
Délai: Day 1
|
Test for differences in the blood of individuals with lung disease and normal healthy controls.
|
Day 1
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Genetic expression of relevant genes between the lung disease and healthy control populations
Délai: Day 1
|
Test for genetic differences in the blood of individuals with lung disease and normal healthy controls.
|
Day 1
|
|
Saliva and urine analysis results compared to blood content results between the lung disease and healthy control populations.
Délai: Day 1
|
Analyze saliva and urine along with the blood sample in order to compare the information in the blood with the saliva and urine.
|
Day 1
|
|
Identify diagnostic and prognostic indicators for lung disease
Délai: December 2020
|
Develop and test possible diagnostic and prognostic indicators for various lung diseases.
|
December 2020
|
|
Develop possible treatment for lung disease
Délai: December 2020
|
Develop and test possible reprogramming of blood cells to promote vessel formation as a way to prevent tumor metastases and modify the progression of specific lung diseases.
|
December 2020
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Clay Marsh, M.D., Ohio State University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
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
Autres numéros d'identification d'étude
- 2011H0007
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