PhenylketonuriasNCT05998109
PheCheck Feasibility Study
An observational study of Phenylketonurias, run by Lumos Diagnostics at 1 site in United States.
Trial summary
The goal of this feasibility study clinical trial is to compare the accuracy of PheCheck™ for the rapid quantitative detection of phenylalanine (Phe) with the gold standard (HPLC amino acid analyzer), in patients with PKU. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Phenylketonurias
- What is being tested?
- PheCheck™, HPLC Amino Acid Analyzer and Dried Blood Spot Cards
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2023to 31 Jul 2024
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients ≥ 10 years who are undergoing monitoring for Phenylketonuria (PKU)
Who may be able to join
- 10 years of age or older
- Being monitored for Phenylketonuria (PKU), hyperphenylalaninemia or for PKU during pregnancy Signed informed consent
Who cannot join
- Younger than 10 years of age
- Not being monitored for Phenylketonuria (PKU), hyperphenylalaninemia or for PKU during pregnancy
- Lack of signed informed consent
- Previous enrollment in the study and has completed study visit 1 and 2
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
About this study
The goal of this feasibility study clinical trial is to compare the accuracy of PheCheck™ for the rapid quantitative detection of phenylalanine (Phe) with the gold standard (HPLC amino acid analyzer), in patients with PKU.
The main aims are:
- Evaluate the accuracy of PheCheck as compared to the gold standard
- Evaluate ease of use by lay participants
Read the detailed description
The primary objective of this feasibility study is to evaluate the accuracy of the analyte concentration of PheCheck™ for the rapid, quantitative detection of phenylalanine (Phe) from capillary blood compared to the gold standard (HPLC amino acid analyzer) which quantitatively measures Phe in venous blood.
The study will enroll subjects into one study cohort. It will include patients 10 years or older, monitored for Phenylketonuria (PKU), hyperphenylalaninemia or PKU during pregnancy.
- Conditions
- Phenylketonurias
- Being tested
- PheCheck™, HPLC Amino Acid Analyzer, Dried Blood Spot Cards
- Medical subject headings
- Phenylketonurias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PheCheck™Device
Quantitative, single-use, rapid test Intended for home-based self-testing and monitoring of PKU.
1 fingerstick specimen collected at each study visit
HPLC Amino Acid AnalyzerDiagnostic test
1 venous specimen collected at each study visit
Dried Blood Spot CardsDiagnostic test
capillary blood specimen collected at each study visit
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of phenylalanine (Phe) from PheCheck as compared to HPLC amino acid analyzer
The primary outcome is the concentration of phenylalanine (Phe) from capillary blood as compared to the gold standard HPLC amino acid analyzer
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start15 Dec 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PhenylketonuriasStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumos Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aptatek BioSciences, Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998109
- Sponsor's protocol ID
- CLP-0012
- Status last verified
- Sep 2025
- First submitted
- 10 Aug 2023
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gondrand C, Reischl-Hajiabadi AT, Bonedeau E, Weiss N, Schneider G, Fahn M, Myers F, Stadle PM, Jeltsch K, Hoffmann GF, Okun JG, Haas D, Garbade SF, Johnsson K, Opladen T. Real-Life Application of a Point-of-Care Biosensor for Phenylalanine in Patients With Phenylketonuria. J Inherit Metab Dis. 2026 May;49(3):e70187. doi: 10.1002/jimd.70187.
PubMed 41989430
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PheCheck Feasibility Study
- ClinicalTrials.gov ID
- NCT05998109
- Acronym / sponsor ID
- CLP-0012
- Conditions
- Phenylketonurias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Lumos DiagnosticsIndustry (pharma, biotech, devices)
- Collaborators
- Aptatek BioSciences, Inc
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 18 Aug 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 goal of this feasibility study clinical trial is to compare the accuracy of PheCheck™ for the rapid quantitative detection of phenylalanine (Phe) with the gold standard (HPLC amino acid analyzer), in patients with PKU.
The main aims are:
- Evaluate the accuracy of PheCheck as compared to the gold standard
- Evaluate ease of use by lay participants
Detailed description
The primary objective of this feasibility study is to evaluate the accuracy of the analyte concentration of PheCheck™ for the rapid, quantitative detection of phenylalanine (Phe) from capillary blood compared to the gold standard (HPLC amino acid analyzer) which quantitatively measures Phe in venous blood.
The study will enroll subjects into one study cohort. It will include patients 10 years or older, monitored for Phenylketonuria (PKU), hyperphenylalaninemia or PKU during pregnancy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients ≥ 10 years who are undergoing monitoring for Phenylketonuria (PKU)
Key inclusion criteria (2 listed)
- 10 years of age or older
- Being monitored for Phenylketonuria (PKU), hyperphenylalaninemia or for PKU during pregnancy Signed informed consent
Key exclusion criteria (4 listed)
- Younger than 10 years of age
- Not being monitored for Phenylketonuria (PKU), hyperphenylalaninemia or for PKU during pregnancy
- Lack of signed informed consent
- Previous enrollment in the study and has completed study visit 1 and 2
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 |
|---|---|---|
| PheCheck™Quantitative, single-use, rapid test Intended for home-based self-testing and monitoring of PKU. 1 fingerstick specimen collected at each study visit | Device | – |
| HPLC Amino Acid Analyzer1 venous specimen collected at each study visit | Diagnostic test | – |
| Dried Blood Spot Cardscapillary blood specimen collected at each study visit | Diagnostic test | – |
Primary outcome
Concentration of phenylalanine (Phe) from PheCheck as compared to HPLC amino acid analyzer
Time frame: 6-8 weeks
The primary outcome is the concentration of phenylalanine (Phe) from capillary blood as compared to the gold standard HPLC amino acid analyzer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Derived from this study: PubMed 41989430Gondrand C, Reischl-Hajiabadi AT, Bonedeau E, Weiss N, Schneider G, Fahn M, Myers F, Stadle PM, Jeltsch K, Hoffmann GF, Okun JG, Haas D, Garbade SF, Johnsson K, Opladen T. Real-Life Application of a Point-of-Care Biosensor for Phenylalanine in Patients With Phenylketonuria. J Inherit Metab Dis. 2026 May;49(3):e70187. doi: 10.1002/jimd.70187.
- Individual participant dataSharing planned: Undecided
Related trials for Phenylketonurias
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Impact of Phenylalanine Elevations on Brain and Cognition in Adult PKU Carriers
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Not yet recruiting
Market Research of a Slow Release Protein Substitute for the Dietary Management of PKU
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Phenylketonurias, run by Lumos Diagnostics at 1 site in United States.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 15 Sep 2025. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of phenylalanine (Phe) from PheCheck as compared to HPLC amino acid analyzer (time frame: 6-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05998109, which also lists 1 linked publication.
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 15 Sep 2025.