- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02445521
Testing of Four Home Phenylalanine Monitoring Prototype Devices
Testing of Four Home Phenylalanine Monitoring Prototype Devices Using Whole Blood From Normal and PKU Subjects
Aperçu de l'étude
Statut
Les conditions
Description détaillée
A real time, point-of-care and home phenylalanine monitoring system would provide patients with quick results and feedback. Home monitoring devices' phenylalanine measurements will be compared to the current gold-standard measurement of phenylalanine (plasma concentration) in four subjects with PKU and one control subject. The study will enroll subjects with different baseline phenylalanine concentrations (i.e., patients with poor to good metabolic control, assessed by comparing current phenylalanine concentrations to established treatment ranges).
For each prototype device, three separate measurements of phenylalanine per subject will be performed. Three prototype devices require whole blood, thus 1 teaspoon (approximately 4mL) of whole blood will be collected through venipuncture and blood spots will be used to conduct tests. One prototype requires capillary blood to be collected through a fingerstick, and will require three blood spots from the stick. A single plasma amino acid analysis for each participant will also be performed using leftover whole blood from the 4mL blood draw through quantitative ion exchange chromatography, reported as micromoles/L.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Georgia
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Atlanta, Georgia, États-Unis, 30322
- Emory University Hospital - Atlanta Clinical and Translational Science Institute (ACTSI)
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Atlanta, Georgia, États-Unis, 30322
- Children's Healthcare of Atlanta (CHOA)
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Decatur, Georgia, États-Unis, 30033
- Emory University Genetics Clinic
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- diagnosis of PKU or hyperphenylalaninemia (PKU group)
- any age
- in good health (PKU and control group)
Exclusion Criteria:
- pregnant
- have any medical comorbidities
- considered unfit for participation by the principal investigator
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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PKU (low phe-level)
A subject diagnosed with phenylketonuria (PKU) with low phenylalanine levels, defined as 1-5 mg/dL
|
PKU (mid phe-level)
A subject diagnosed with phenylketonuria (PKU) with middle phenylalanine levels, defined as 6-10 mg/dL
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PKU (high mid phe-level)
A subject diagnosed with phenylketonuria (PKU) with high middle phenylalanine levels, defined as 11-15 mg/dL
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PKU (high phe-level)
A subject diagnosed with phenylketonuria (PKU) with high phenylalanine levels, defined as 16-20+ mg/dL
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Control
A normal subject without phenylketonuria (PKU)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Intra-variability of the four devices, assessed by phenylalanine values
Délai: Day 1
|
Phenylalanine values for each of the three runs on each device for the same individual will be compared.
Each PKU subject will be assessed separately to assess the reliability of each device since the subjects will have a range of phenylalanine concentrations.
|
Day 1
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Inter-variability of the four devices, assessed by average phenylalanine concentrations
Délai: Day 1
|
Average phenylalanine values measured by the four tests of each device in each subject will be calculated.
Mean concentrations for each device will be compared to the control (gold standard measure of plasma phenylalanine).
|
Day 1
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Rani H Singh, PhD, RD, LD, Emory University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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 (Estimation)
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
- IRB00079788
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