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NCT05998109 · ClinicalTrials.gov registry record
PheCheck Feasibility Study
A clinical trial of Phenylketonurias, sponsored by Lumos Diagnostics.
- Completed
- Registry status
- 30
- Enrollment target
- 1
- Study location
NCT05998109: Completed study of Phenylketonurias, sponsored by Lumos Diagnostics.
NCT05998109 is a study of Phenylketonurias that has completed, run by Lumos Diagnostics. The registered enrollment target is 30 participants, below the 40-participant average among 5 other Phenylketonurias trials with a reported enrollment target (25% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05998109, a study of Phenylketonurias, has completed, sponsored by Lumos Diagnostics.
- COMPLETED
- Registry status
- 30 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
The primary outcome is the concentration of phenylalanine (Phe) from capillary blood as compared to the gold standard HPLC amino acid analyzer
Conditions Studied
Interventions
- DEVICE PheCheck™
- DIAGNOSTIC_TEST HPLC Amino Acid Analyzer
- DIAGNOSTIC_TEST Dried Blood Spot Cards
Study Locations (1)
Pennsylvania
- UPMC Children's Hospital of Pittsburgh - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-12-15 |
| Est. Completion | 2024-07-31 |
What the finished NCT05998109 record still lists
NCT05998109 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 40-participant average among 5 other Phenylketonurias trials with a reported enrollment target (25% lower).
The record links to 1 condition, with Phenylketonurias appearing as the primary indexed condition, and to 3 interventions - of which PheCheck™ is the first listed.
NCT05998109 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05998109 about?
NCT05998109 is a clinical study titled "PheCheck Feasibility 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 g...
What is the current status of trial NCT05998109?
This trial is currently completed. The enrollment target is 30 participants. The study started on 2023-12-15. Estimated completion is 2024-07-31.
What conditions does trial NCT05998109 study?
This clinical trial studies the following conditions: Phenylketonurias.
What interventions are being tested in trial NCT05998109?
The interventions under investigation include: PheCheck™ (DEVICE), HPLC Amino Acid Analyzer (DIAGNOSTIC_TEST), Dried Blood Spot Cards (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05998109?
This trial is sponsored by Lumos Diagnostics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05998109 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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