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

NCT05894122 | Unknown

• 2 other identifiers: 38RC22.03192023-A01180-45
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Phenylketonuria; Metabolic Diseases

Outcome Measures

Primary Outcomes (1)

• Comparison of phenylalanine concentrations

  Comparison of phenylalanine concentrations in the new device with those in the current device (blotter).

  Day 1

Secondary Outcomes (5)

• Ease of use of research device

  Day 1

• sample conformity

  Day 1

• comparison of concentrations of tyrosin

  Day 1

• comparison of concentrations of total leucin

  Day 1

• comparison of concentrations of methionin

  Day 1

Interventions

DM-DIV MITRA® DIAGNOSTIC_TEST

Comparison of phenylalanine concentrations in the new device with those in the current device (blotter).

Also known as: DM-DIV HemaPEN®

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric population

You may qualify if:

• 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.

You may not qualify if:

• Parents or legal guardians opposed to the MitrAlanine study

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHU Grenoble Alpes

Grenoble, 38043, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood collection on blotters : DM-DIV MITRA® and DM-DIV HemaPEN® for research and Perkin Elmer device for care

MeSH Terms

Conditions

Phenylketonurias; Metabolic Diseases

Condition Hierarchy (Ancestors)

Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases

Central Study Contacts

Christelle CORNE, MD

CONTACT

04 76 76 92 32; CCorne@chu-grenoble.fr

Caroline TOURNEGROS, CRA

CONTACT

04 76 76 67 30; CTournegros@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 8, 2023
• Study Start: December 13, 2023
• Primary Completion: December 12, 2025
• Study Completion: December 12, 2025
• Last Updated: December 22, 2023

Record last verified: 2023-12

Locations

FR (1)