PhenylketonuriaMitrAlanineNCT05894122
Evaluation of Capillary Blood Collection Devices (Mitra® and HemaPEN®)
An observational study of Phenylketonuria and Metabolic Diseases, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Phenylketonuria, Metabolic Diseases
- What is being tested?
- DM-DIV MITRA®
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 13 Dec 2023to 12 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric population
Who may be able to join
- 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.
Who cannot join
- Parents or legal guardians opposed to the MitrAlanine study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Grenoble Alpes
Grenoble, 38043
Christelle CORNE, +33 (0)4 76 76 92 32, CCorne@chu-grenoble.fr
About this study
Official title: Evaluation of Capillary Blood Collection Devices (Mitra® and HemaPEN®) in the Context of Metabolic Diseases and, in Particular, Pediatric Monitoring of Phenylketonuria
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
- Being tested
- DM-DIV MITRA®
- Medical subject headings
- Phenylketonurias, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DM-DIV MITRA®Diagnostic test
Also called DM-DIV HemaPEN®
Comparison of phenylalanine concentrations in the new device with those in the current device (blotter).
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of phenylalanine concentrations
Comparison of phenylalanine concentrations in the new device with those in the current device (blotter).
Measured: Day 1
Secondary outcomes (5)
Ease of use of research device
ease of use of DM-DIV MITRA® and DM-DIV HemaPEN® via a 3 questions-and-answer guide for samplers
Measured: Day 1
sample conformity
Conformity of blood sample on DM-DIV MITRA® and DM-DIV HemaPEN® versus DM-DIV Perkin Elmer
Measured: Day 1
comparison of concentrations of tyrosin
comparison of concentrations of other amino acids (tyrosin) dosed at the same time as phenylalanine
Measured: Day 1
comparison of concentrations of total leucin
comparison of concentrations of other amino acids (total leucin) dosed at the same time as phenylalanine
Measured: Day 1
comparison of concentrations of methionin
comparison of concentrations of other amino acids (methionin) dosed at the same time as phenylalanine
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start13 Dec 2023
- Primary completion12 Dec 2025 (estimated)
- Study completion12 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhenylketonuriaStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894122
- Sponsor's protocol ID
- 38RC22.0319
- Other IDs
- 2023-A01180-45
- Acronym
- MitrAlanine
- Status last verified
- Dec 2023
- First submitted
- 30 May 2023
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Capillary Blood Collection Devices (Mitra® and HemaPEN®) in the Context of Metabolic Diseases and, in Particular, Pediatric Monitoring of Phenylketonuria
- ClinicalTrials.gov ID
- NCT05894122
- Acronym / sponsor ID
- MitrAlanine / 38RC22.0319
- Conditions
- Phenylketonuria, Metabolic Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 12 Dec 2025 (estimated)
- Study completion
- 12 Dec 2025 (estimated)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric population
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Parents or legal guardians opposed to the MitrAlanine study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DM-DIV MITRA®Also: DM-DIV HemaPEN®Comparison of phenylalanine concentrations in the new device with those in the current device (blotter). | Diagnostic test | – |
Primary outcome
Comparison of phenylalanine concentrations
Time frame: Day 1
Comparison of phenylalanine concentrations in the new device with those in the current device (blotter).
5 secondary outcomes
Ease of use of research device
Time frame: Day 1
sample conformity
Time frame: Day 1
comparison of concentrations of tyrosin
Time frame: Day 1
comparison of concentrations of total leucin
Time frame: Day 1
comparison of concentrations of methionin
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Phenylketonuria and Metabolic Diseases, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christelle CORNE, MD (04 76 76 92 32 ext. +33, CCorne@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of phenylalanine concentrations (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.