NCT06689410

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,100

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

26 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Mar 2025Mar 2027

First Submitted

Initial submission to the registry

October 31, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 14, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

March 25, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2027

Last Updated

May 29, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

October 31, 2024

Last Update Submit

May 26, 2026

Conditions

Keywords

intracranial aneurysmphenotypegeneticsimagingmultimodal 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

Collection of blood or saliva

ICA cases

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

RECRUITING

CHU Amiens

Amiens, France

NOT YET RECRUITING

CHU Angers

Angers, France

NOT YET RECRUITING

CHU Besançon

Besançon, France

NOT YET RECRUITING

CHU Bordeaux Hôpital Pellegrin

Bordeaux, France

NOT YET RECRUITING

CHU de Brest

Brest, France

NOT YET RECRUITING

CHU Caen-Normandie

Caen, France

NOT YET RECRUITING

CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

CHU Limoges

Limoges, France

NOT YET RECRUITING

APHM

Marseille, France

NOT YET RECRUITING

CHU de Montpellier

Montpellier, France

NOT YET RECRUITING

CHRU de Nancy

Nancy, France

NOT YET RECRUITING

GHU Paris - Hôpital Ste Anne

Paris, France

NOT YET RECRUITING

Hôpital Fondation Rothschild

Paris, France

NOT YET RECRUITING

Hôpital La Pitié Salpêtrière

Paris, France

NOT YET RECRUITING

Hôpital Lariboisière

Paris, France

NOT YET RECRUITING

CHU de Poitiers

Poitiers, France

NOT YET RECRUITING

CHU de Reims

Reims, France

NOT YET RECRUITING

CHU Rennes

Rennes, France

NOT YET RECRUITING

CHU de Rouen

Rouen, France

NOT YET RECRUITING

CHU St Etienne

Saint-Etienne, France

NOT YET RECRUITING

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

NOT YET RECRUITING

Hôpital Foch

Suresnes, France

NOT YET RECRUITING

HIA Sainte-Anne

Toulon, France

NOT YET RECRUITING

CHU de Toulouse

Toulouse, France

NOT YET RECRUITING

CHRU Tours Hôpital Bretonneau

Tours, France

NOT YET RECRUITING

MeSH Terms

Conditions

AneurysmIntracranial AneurysmCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesIntracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Romain BOURCIER, MD

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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 29, 2026

Record last verified: 2026-04

Locations