Multimodal Biocollection Linked to the French Register of Intracranial Aneurysms

NCT ID: NCT06689410

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-25
• Study Completion Date: 2028-04-01

Brief Summary

The purpose of the bCAN study is to create a prospective collection of multimodal data and human samples, linked to the French Intracranial Aneurysm Registry (FRAN).

The aim of bCAN is to enable risk stratification of ruptured ICAs by redefining "intracranial aneurysm disease". The description of genotypically and phenotypically specific subgroups of cases will pave the way for improved patient management based on new diagnostic/prognostic strategies among AIC carriers, either in a familial context, or at the level of the general population.

Detailed Description

The main objective of bCAN study is to build a predictive model of intracranial aneurysm phenotypes through the combination of information on genetic mutations, imaging findings and ICA rupture characteristics.

The secondary objectives of the bCAN study are (i) to study morphological characterization of ICA and vascular bifurcations, (ii) to deepen knowledge of genotype/clinical and biological phenotype relationships according to the genes identified in the different families, (iii) to research and validate the relationships between genotypes and phenotypes (including rupture) of ICA in a large population of sporadic ICA cases.

Conditions

Aneurysm; Brain Aneurysm; Congenital Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

ICA cases

Any adult patient consulting for a definite and typical bifurcation AIC authenticated on MRI and/or cerebral arteriography

Group Type: OTHER

blood or saliva sample

Intervention Type: OTHER

Collection of blood or saliva

Interventions

blood or saliva sample

Collection of blood or saliva

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Any adult patient consulting for a definite and typical bifurcation AIC authenticated on MRI and/or cerebral arteriography
• Aneurysm discovered less than a year ago, with initial imaging (MRI and/or CTA and DSA) available
• Written consent obtained for study participation
• Patient covered by a social security plan

• Index case: Any adult patient consulting for a definite and typical bifurcation ICA presenting at least one other case with ICA related to the 1st or 2nd degree (child, parent, brother, sister) detected by MRI with at least one Time of Flight (TOF) sequence.
• Family relatives: All 1st- and 2nd-degree relatives (children, parents, brothers, sisters), of legal age, of patients with a family history of definite, typical bifurcation AIC (≥ 2 affected), Screening to be performed using MRI with at least a Time of Flight (TOF) sequence.
• Written consent to participate in the study
• Patient and relatives covered by a social security plan

Exclusion Criteria

• Syndromic diagnosis known to cause ICA: Marfan syndrome, OSA with SMAD 3, Elhers Danlos syndrome type II and IV, Autosomal Dominant Cystic Fibrosis, Moya-Moya syndrome
• AIC with : Dissecting or fusiform, Associated with arteriovenous malformation, Blister-like, Mycotic
• Cerebral white matter pathology detected on MRI evoking : Col4a1 mutation
• Patient under guardianship or conservatorship
• Person under court protection
• Contraindication to an MRI scan

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federation of Medical Specialties

OTHER

Sponsor Role: collaborator

Inserm UMR1087, CNRS UMR6291

UNKNOWN

Sponsor Role: collaborator

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Romain BOURCIER, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

Nantes University Hospital

Nantes, Loire-Atlantique, France

Site Status: RECRUITING

Countries

France

Central Contacts

Romain BOURCIER, MD

Role: CONTACT

romain.bourcier@chu-nantes.fr

33240165608

Other Identifiers

RC24_0512

Identifier Type: -

Identifier Source: org_study_id