Clinical trial
Risk Stratification of Sudden Unexpected Death in Infant Based on Biomarkers - Identification of Genetic Variants Associated With Unexpected Infant Death Syndrome
Name
RC23_0260
Description
This is a multicenter genetic study aimed at identifying new genes/variants associated with sudden infant death syndrome (SIDS) based on whole-genome sequencing of family trios
Trial arms
Trial start
2024-02-01
Estimated PCD
2026-02-01
Trial end
2027-04-01
Status
Not yet recruiting
Treatment
whole genome sequencing
Study of all coding and non-coding sequences in the genome to identify pathogenic allelic variants
Arms:
Parents, SUDI cases
Size
650
Primary endpoint
Identification of genetic variants
up to 38 months
Eligibility criteria
Child Inclusion Criteria
* Death of a child between 0 and 2 years of age due to sudden unexpected death in infant
* Child included in the French SUDI registry with effective participation in the biocollection
* Children who also meet the inclusion criteria for the BIOMINRISK-NEUROBIO (axis 2) and BIOMINRISK-RADIO-ANAT (axis 3) studies in the overall BIOMINRISK project.
Parents Inclusion Criteria
* Biological parents of the child included in the BIOMINRISK study
* Parents who have both signed the consent form for blood collection and inclusion of their samples in the biocollection
* parents beneficiaries of a social security or similar scheme
Child Exclusion Criteria:
* Presence of a known metabolic, genetic or syndromic pathology at the time of death
Parents Exclusion Crtiteria:
* Parent under guardianship
* Presence of a known metabolic, genetic or syndromic pathology
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'FAMILY_BASED', 'timePerspective': 'CROSS_SECTIONAL'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood and DNA samples'}, 'enrollmentInfo': {'count': 650, 'type': 'ESTIMATED'}}
Updated at
2024-02-06
1 organization
1 product
2 indications
Organization
Nantes University HospitalProduct
Whole Genome SequencingIndication
Sudden Infant DeathIndication
Sudden Infant Death Syndrome