Multimodal Biocollection Linked to the French Register of Intracranial Aneurysms

NCT06689410 | Recruiting

• 1 other identifier: RC24_0512
• Study Type: interventional
• Target: 1,100
• Locations: 1 country
• Sites: 2

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.

Conditions

Aneurysm; Brain Aneurysm; Congenital Disease

Keywords

intracranial aneurysm; phenotype; genetics; imaging; multimodal data

Outcome Measures

Primary Outcomes (1)

• Performance of a predictive model allowing the classification of ICA subphenotypes

  The performance of a predictive model allowing the classification of ICA subphenotypes will be analysed through the study of genetic results, quantitative features extracted from imaging and clinical data on rupture

  36 months

Secondary Outcomes (4)

• Characterization of arterial bifurcations

  36 months

• Characterization of aneurysmal sacs

  36 months

• Screening of genetic mutations

  36 months

• Correlation between genotypes and phenotypes

  36 months

Study Arms (1)

ICA cases

OTHER

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

Other: blood or saliva sample

Interventions

blood or saliva sample OTHER

Collection of blood or saliva

ICA cases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (child, parent, brother, sister) detected by MRI with at least one Time of Flight (TOF) sequence.
• Family relatives: children, parents, brothers, sisters, of legal age, of patients with a family history of definite, typical bifurcation AIC (≥ 4 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead
• Federation of Medical Specialties: collaborator

Study Sites (2)

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

RECRUITING

CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

MeSH Terms

Conditions

Aneurysm; Intracranial Aneurysm; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Romain BOURCIER, MD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Romain BOURCIER, MD

CONTACT

33240165608; romain.bourcier@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 14, 2024
• Study Start: March 25, 2025
• Primary Completion (Estimated): March 25, 2027
• Study Completion (Estimated): March 25, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

FR (2)