PheCheck Feasibility Study
- Conditions
- Phenylketonurias
- Registration Number
- NCT05998109
- Lead Sponsor
- Lumos Diagnostics
- Brief 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.
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 10 years of age or older
- Being monitored for Phenylketonuria (PKU), hyperphenylalaninemia or for PKU during pregnancy Signed informed consent
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Concentration of phenylalanine (Phe) from PheCheck as compared to HPLC amino acid analyzer 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UPMC Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States