Determining the Most Efficient Screening Cut Off Levels f... | NCT06629987

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

NCT06629987

Sponsor

Central Hospital, Nancy, France

Status

Completed

Last Update Posted

Oct 9, 2024Actual

Enrollment

360Actual

Phase

Not provided

Conditions

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Jan 1, 2021Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

Oct 4, 2024

First Submission Date that Met QC Criteria

Oct 4, 2024

First Posted Date

Oct 8, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 5, 2024

Last Update Posted Date

Oct 9, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

HESS Valentin, MD, Principal Investigator, Central Hospital, Nancy, FrancePrincipal Investigator

Lead Sponsor

Central Hospital, Nancy, FranceOTHER

Collaborators

Name	Class
University Hospital, Lille	OTHER
Hospices Civils de Lyon	OTHER
University Hospital, Strasbourg, France	OTHER
CHU de Reims

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

studying the screening of PKU in france with the new tandemMS

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

360Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
developping an PKU: id phenylanine over 360µmol/L	based on level of phenylalanine during the year of follow up	1 year

Secondary Outcomes

Measure	Description	Time Frame
screening value	determining the bets screening value	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

having screening in france

Exclusion Criteria:

refusing neonatal screening

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Days

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

all french population born who had a screening

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU NANCY hopital enfant		Nancy		54000	France