Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06300567
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-03-02
Brief Title:
Assessment of Patients Not Concluded After Neonatal Screening of Cystic Fibrosis
Sponsor:
Hôpital Necker-Enfants Malades
Organization:
Hôpital Necker-Enfants Malades
Study Overview
Official Title:
Assessment of Patients Not Concluded After Neonatal Screening of Cystic Fibrosis CFTR-RD Misdiagnosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Assessment of the outcome of patients not concluded fir cystic fibrosis either symptomatic patients or asymptomatic children detected by newborn screening for cystic fibrosis The aim is to identify patients potentially at risk of progressing to the clinical spectrum of cystic fibrosis
Detailed Description:
Among patients not concluded for the diagnosis of cystic fibrosis some are carriers of CFTR-RD mutations therefore at risk of progressing to a symptomatic form and may already have a subclinical involvement that it is important to identify Among patients who do not carry the CFTR-RD genotype other patients may be at risk of developing symptoms if they are carriers of an undetected variant or wrongly classified as non-pathogenic It is important to detect them to prevent the onset of symptoms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None