NCT06629987

Brief Summary

studying the screening of PKU in france with the new tandemMS

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
Last Updated

October 9, 2024

Status Verified

October 1, 2024

Enrollment Period

Same day

First QC Date

October 4, 2024

Last Update Submit

October 5, 2024

Conditions

PKU

Keywords

screening

Outcome Measures

Primary Outcomes (1)

  • developping an PKU: id phenylanine over 360µmol/L

    based on level of phenylalanine during the year of follow up

    1 year

Secondary Outcomes (1)

  • screening value

    2 years

Eligibility Criteria

Age3 Days+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all french population born who had a screening

You may qualify if:

  • having screening in france

You may not qualify if:

  • refusing neonatal screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU NANCY hopital enfant

Nancy, 54000, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Principal Investigator

Study Record Dates

First Submitted

October 4, 2024

First Posted

October 8, 2024

Study Start

January 1, 2021

Primary Completion

January 1, 2021

Study Completion

December 31, 2022

Last Updated

October 9, 2024

Record last verified: 2024-10

Locations

FR(1)