PheCheck Feasibility Study

Description

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

Conditions

Phenylketonurias

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Study Overview

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Study Details

Study overview

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

PheCheck Feasibility Study

PheCheck Feasibility Study

Condition
Phenylketonurias
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States, 15224

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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

Ages Eligible for Study

10 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Lumos Diagnostics,

Study Record Dates

2024-03-15