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Genetic Newborn Screening for Rare Diseases Within the Screen4Care Project

Study acronym: SCREEN4CARE
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary and study completion dates: Dec 2025 to Dec 2026
    • Study sites: 6 to 8
    • Collaborators: 11 to 18
    v7
  2. Study sites: 5 to 6
    • Collaborators: 10 to 11
    v6
  3. Site details revised at 3 of 5 sitesv5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 2024 to Dec 3, 2024
    • Site details revised at 5 of 5 sites
    v4
  5. Site contacts updated at 1 of 5 sitesv3
  6. Start date: Sep 2024 to Nov 2024v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06549218
Lead Sponsor University Hospital Freiburg
Collaborators: Innovative Medicines Initiative, Università degli Studi di Ferrara, Ospedale Pediatrico Bambin Gesù, University of Siena, Centre Hospitalier Universitaire Dijon, Real Genix, University Hospital Goettingen, Centro Nacional de Análisis Genómico, Genoox, Municipal Hospital Karlsruhe, Schwarzwald-Baar Hospital, Illumina, Inc., Charite University, Berlin, Germany, Brno University Hospital, General Hospital Of Thessaloniki Ippokratio, San Camillo Hospital, Rome, University of Rzeszow, Hospital San Pietro Fatebenefratelli
Conditions
(from sponsor)		 Newborn Screening
Enrollment 20,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov