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CompletedNCT06629987Updated Oct 9, 2024

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

An observational study in PKU, sponsored by Central Hospital, Nancy, France. Completed at 1 site in France. Open to participants aged 3 Days and older. Per ClinicalTrials.gov, last updated 2024-10-09.

Sponsored by Central Hospital, Nancy, France · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
360
Ages
3 Days and older
Sex
All
01

Study summary

studying the screening of PKU in france with the new tandemMS

Read the detailed description

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

02

Conditions studied

  • PKU

Keywords

  • screening
03

In context

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 797 studies on the registry; 188 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Days and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

all french population born who had a screening

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • having screening in france

Exclusion criteria

Exclusion Criteria:

  • refusing neonatal screening
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
360 participants (actual)
Target follow-up
1 Year
Patient registry
Yes
06

What researchers measure

Primary outcomes

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

    based on level of phenylalanine during the year of follow up

    Time frame: 1 year

Secondary outcomes

  1. screening value

    determining the bets screening value

    Time frame: 2 years

07

Study locations

1 site
  • CHRU NANCY hopital enfant
    Nancy, 54000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06629987
Lead sponsor
Central Hospital, Nancy, France
Collaborators
University Hospital, Lille, Hospices Civils de Lyon, University Hospital, Strasbourg, France, CHU de Reims, Centre Hospitalier Universitaire, Amiens, Centre Hospitalier Universitaire Dijon, Nantes University Hospital, University Hospital, Tours, Clinical Research Center of Reunion island, University Hospital, Caen, Rennes University Hospital, University Hospital, Bordeaux, University Hospital, Toulouse, University Hospital, Montpellier
Responsible party
HESS Valentin (MD, Principal Investigator, Central Hospital, Nancy, France) — Principal investigator
First posted
Oct 8, 2024
Start date
Jan 1, 2021
Primary completion
Jan 1, 2021
Completion
Dec 31, 2022
Last update
Oct 9, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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