Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549218
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Genetic Newborn Screening for Rare Diseases Within the Screen4Care Project
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Shortening the Path to Rare Disease Diagnosis by Using Newborn Genetic Screening and Digital Technologies SCREEN4CARE Genetic Newborn Screening for Rare Diseases Within the Screen4Care Project
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCREEN4CARE
Brief Summary:
The main objective of the genetic newborn screening part of the Screen4Care-project is to shorten the path to rare disease diagnosis and to facilitate early intervention Therefore genetic newborn screening for currently treatable rare diseases TREAT-panel approach will be offered to families expecting a baby Whole genome sequencing WGS will be offered as additional diagnostic approach to newborns participating in Screen4Care TREAT-panel approach if they develop symptoms suggestive of a genetic disease
To evaluate to what extend genetic newborn screening has an impact on participating infants and their families a follow-up with standardised questionnaires will be performed for all participating families
To evaluate to what extend genetic newborn screening has an impact on participating infants and their families a follow-up with standardised questionnaires will be performed for all participating families
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None