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PheCheck Feasibility Study

Sponsor
Lumos Diagnostics (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05998109
Collaborator
Aptatek Biosciences (Other)
30
Enrollment
1
Location
2.1
Anticipated Duration (Months)
14.5
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: PheCheck™
  • Diagnostic Test: HPLC Amino Acid Analyzer
  • Diagnostic Test: Dried Blood Spot Cards

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

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
PheCheck Feasibility Study
Anticipated Study Start Date :
Aug 17, 2023
Anticipated Primary Completion Date :
Sep 28, 2023
Anticipated Study Completion Date :
Oct 19, 2023

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 10 years of age or older

  • Being monitored for Phenylketonuria (PKU), hyperphenylalaninemia or for PKU during pregnancy Signed informed consent

Exclusion Criteria:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UPMC Children's Hospital of Pittsburgh Pittsburgh Pennsylvania United States 15224

Sponsors and Collaborators

  • Lumos Diagnostics
  • Aptatek Biosciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lumos Diagnostics
ClinicalTrials.gov Identifier:
NCT05998109
Other Study ID Numbers:
  • CLR-0012
First Posted:
Aug 18, 2023
Last Update Posted:
Aug 18, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Phenylketonurias

Study Results

No Results Posted as of Aug 18, 2023