Identification of Genetic Variants Associated With Unexpected Infant Death Syndrome
NCT ID: NCT06244433
Last Updated: 2025-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
650 participants
OBSERVATIONAL
2024-08-27
2027-10-31
Brief Summary
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Detailed Description
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This is a multicenter (15 centers), national, non-randomized, open-label, genetic study. Sudden unexpected death in infant (SUDI) cases will be included (i) partly retrospectively (infants already included in the national French SUDI registry) and (ii) for the other cases, prospectively at the time of care of the deceased infant by the referral center of SUDI participating in the project. The parents making up the trios will be included prospectively.
Once the Sudden infant death syndrome (SIDS) cases have been identified among all the included SUDI cases (following the results of post-mortem examinations), Whole Genome Sequencing (WGS) will be carried out on these SIDS cases and their two parents, in order to identify pathogenic allelic variants. The data generated by this sequencing will then be analyzed using a trio approach to search for de novo variants, i.e. variants present in the infant who died of SIDS and absent from the genome of both parents.
Conditions
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Study Design
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FAMILY_BASED
CROSS_SECTIONAL
Study Groups
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SUDI cases
Sudden unexpected death in infant (SUDI) cases registered within the French National Registry of SUDI
whole genome sequencing
Study of all coding and non-coding sequences in the genome to identify pathogenic allelic variants
Parents
Both parents of identified SUDI
whole genome sequencing
Study of all coding and non-coding sequences in the genome to identify pathogenic allelic variants
Interventions
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whole genome sequencing
Study of all coding and non-coding sequences in the genome to identify pathogenic allelic variants
Eligibility Criteria
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Inclusion Criteria
* Child included in the French SUDI registry with effective participation in the biocollection
* 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
Exclusion Criteria
Parents Exclusion Crtiteria:
* Parent under guardianship
* Presence of a known metabolic, genetic or syndromic pathology
ALL
No
Sponsors
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AXA Assurances VIE Mutuelle
UNKNOWN
Institut du Thorax
UNKNOWN
Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Fleur Lorton
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Locations
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Nantes University Hospital
Nantes, Loire-Atlantique, France
CHU Amiens
Amiens, , France
CHU Angers
Angers, , France
CHU Besançon
Besançon, , France
APHP - Hôpital Jean Verdier
Bondy, , France
CHU Brest
Brest, , France
APHP - Hôpital Antoine Béclère
Clamart, , France
CHU Grenoble
Grenoble, , France
HCL
Lyon, , France
AP-HM
Marseille, , France
CHU Montpellier
Montpellier, , France
CHRU Nancy
Nancy, , France
CHU Rouen
Rouen, , France
CHU Saint Etienne
Saint-Etienne, , France
CHU Toulouse
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Coralie Degorre
Role: primary
Estelle Darviot
Role: primary
Clémence Mougey
Role: primary
Loïc de Pontual
Role: primary
Mathilde Granjon
Role: primary
Gilles Jourdain
Role: primary
Anne-Pascale Michard-Lenoir
Role: primary
Béatrice Kugener
Role: primary
Laura Bourgoin
Role: primary
Odile Pidoux
Role: primary
Anne Borsa-Dorion
Role: primary
Solenn Raymond
Role: primary
Hugues Patural
Role: primary
Rémi Vincent
Role: primary
References
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Ducloyer M, Baruteau AE, Franco P, Guyon A, Sapin V, Karakachoff M, Savall F, Schott JJ, de Pontual L, De Visme S, Ferrand L, Jarry B, Beudin D, Scherdel P, Lorton F. Identification of novel genetic, neurobiological and radio-anatomical biomarkers for risk stratification of sudden unexpected death in infancy and early childhood: the BIOMINRISK study protocol. BMJ Open. 2025 Jul 30;15(7):e101811. doi: 10.1136/bmjopen-2025-101811.
Other Identifiers
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RC23_0260
Identifier Type: -
Identifier Source: org_study_id
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