MitrAlanine: Evaluation of Capillary Blood Collection Devices (Mitra® and HemaPEN®)

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05894122

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The aim is to demonstrate a new application for a blood collection device. This device is already widely used in pharmacology. It is not currently used for metabolic diseases.

Its ease of use enables repeated sampling at home. What's more, the device can be sent by post, making it ideally suited to the needs of this cohort of children, whose phenylalanine levels need to be monitored very regularly.

Condition or Disease	Intervention/Treatment	Phase
Phenylketonuria Metabolic Diseases	Diagnostic Test: DM-DIV MITRA®

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Evaluation of Capillary Blood Collection Devices (Mitra® and HemaPEN®) in the Context of Metabolic Diseases and, in Particular, Pediatric Monitoring of Phenylketonuria

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Oct 1, 2025

Outcome Measures

Primary Outcome Measures

Comparison of phenylalanine concentrations [Day 1]
Comparison of phenylalanine concentrations in the new device with those in the current device (blotter).

Secondary Outcome Measures

Ease of use of research device [Day 1]
ease of use of DM-DIV MITRA® and DM-DIV HemaPEN® via a 3 questions-and-answer guide for samplers
sample conformity [Day 1]
Conformity of blood sample on DM-DIV MITRA® and DM-DIV HemaPEN® versus DM-DIV Perkin Elmer
comparison of concentrations of tyrosin [Day 1]
comparison of concentrations of other amino acids (tyrosin) dosed at the same time as phenylalanine
comparison of concentrations of total leucin [Day 1]
comparison of concentrations of other amino acids (total leucin) dosed at the same time as phenylalanine
comparison of concentrations of methionin [Day 1]
comparison of concentrations of other amino acids (methionin) dosed at the same time as phenylalanine

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Months to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Children aged 3 months to 18 years
suffering from phenylketonuria or hyperphenylalaninemia
who have had a capillary and blood test including a phenylalanine assay at CHUGA
Whose parents or legal guardians are affiliated to the social security system.
For whom parents or legal guardians have not objected to the MitrAlanine study.

Exclusion Criteria:

Parents or legal guardians opposed to the MitrAlanine study

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Grenoble

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Grenoble

ClinicalTrials.gov Identifier:

NCT05894122

Other Study ID Numbers:

38RC22.0319
2023-A01180-45

First Posted:

Jun 8, 2023

Last Update Posted:

Jun 9, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Phenylketonurias

Metabolic Diseases

Study Results

No Results Posted as of Jun 9, 2023