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OpenTrials
Completed

NCT Number: NCT06629987

Determining the Most Efficient Screening Cut Off Levels for Phenylketonuria (PKU)

studying the screening of PKU in france with the new tandemMS

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Key information

Conditions

PKU

Age range

3 day and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU NANCY hopital enfant

Nancy, 54000, France

About this study

Nationwide cohort study of the new pku screening for patient beetwen 180 and 360 µmol/L.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • having screening in france

Exclusion criteria

  • refusing neonatal screening

Treatment and study plan

Primary outcomes

  1. developping an PKU: id phenylanine over 360µmol/L

    Time frame: 1 year

    based on level of phenylalanine during the year of follow up

Secondary outcomes

  1. screening value

    Time frame: 2 years

    determining the bets screening value

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Collaborators

  • CHU de Reims
  • Centre Hospitalier Universitaire Dijon
  • Centre Hospitalier Universitaire, Amiens
  • Clinical Research Center of Reunion island
  • Hospices Civils de Lyon
  • Nantes University Hospital
  • Rennes University Hospital
  • University Hospital, Bordeaux
  • University Hospital, Caen
  • University Hospital, Lille
  • University Hospital, Montpellier
  • University Hospital, Strasbourg, France
  • University Hospital, Toulouse
  • University Hospital, Tours

Registry information

Official study title

Determining the Most Efficient Screening Cut Off Levels for Phenylketonuria (PKU) by Assessing Two Years of Screening with Tandem Mass Spectrometry (MS) : a French National Cohort Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Oct 8, 2024
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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