Multimodal Biocollection Linked to the French Register of Intracranial Aneurysms (bCAN)

May 26, 2026 updated by: Nantes University Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Amiens, France
        • Not yet recruiting
        • CHU Amiens
        • Contact:
        • Principal Investigator:
          • Cyril CHIVOT
      • Angers, France
        • Not yet recruiting
        • CHU Angers
        • Contact:
        • Principal Investigator:
          • Vincent L'ALLINEC
      • Besançon, France
        • Not yet recruiting
        • CHU Besançon
        • Contact:
        • Principal Investigator:
          • Alessandra BIONDI
      • Bordeaux, France
        • Not yet recruiting
        • CHU Bordeaux Hôpital Pellegrin
        • Principal Investigator:
          • Gaultier MARNAT
        • Contact:
      • Brest, France
      • Caen, France
        • Not yet recruiting
        • CHU Caen-Normandie
        • Contact:
        • Principal Investigator:
          • Charlotte BARBIER
      • Clermont-Ferrand, France, 63000
        • Recruiting
        • CHU Clermont-Ferrand
        • Contact:
        • Principal Investigator:
          • Géraud FORESTIER
      • Limoges, France
        • Not yet recruiting
        • CHU Limoges
        • Principal Investigator:
          • Aymeric ROUCHAUD
        • Contact:
      • Marseille, France
        • Not yet recruiting
        • APHM
        • Contact:
        • Principal Investigator:
          • Jean-François HAK
      • Montpellier, France
        • Not yet recruiting
        • CHU de Montpellier
        • Contact:
        • Principal Investigator:
          • Cyril DARGAZANLI
      • Nancy, France
        • Not yet recruiting
        • CHRU de Nancy
        • Contact:
        • Principal Investigator:
          • François ZHU
      • Paris, France
        • Not yet recruiting
        • Hôpital Lariboisière
        • Contact:
        • Principal Investigator:
          • Marc-Antoine LABEYRIE
      • Paris, France
        • Not yet recruiting
        • Hôpital La Pitié Salpêtrière
        • Contact:
        • Principal Investigator:
          • Eimad SHOTAR
      • Paris, France
        • Not yet recruiting
        • GHU Paris - Hôpital Ste Anne
        • Contact:
        • Principal Investigator:
          • Olivier NAGGARA
      • Paris, France
        • Not yet recruiting
        • Hôpital Fondation Rothschild
        • Contact:
        • Principal Investigator:
          • Jean-Philippe DESILLES
      • Poitiers, France
        • Not yet recruiting
        • CHU de Poitiers
        • Contact:
        • Principal Investigator:
          • Samy BOUCEBCI
      • Reims, France
        • Not yet recruiting
        • CHU de Reims
        • Contact:
        • Principal Investigator:
          • Sébastien SOIZE
      • Rennes, France
        • Not yet recruiting
        • CHU Rennes
        • Contact:
        • Principal Investigator:
          • François EUGENE
      • Rouen, France
        • Not yet recruiting
        • CHU de Rouen
        • Contact:
        • Principal Investigator:
          • Julien BUREL
      • Saint-Etienne, France
        • Not yet recruiting
        • CHU St Etienne
        • Contact:
        • Principal Investigator:
          • Marina SACHET
      • Strasbourg, France
        • Not yet recruiting
        • Hopitaux Universitaires de Strasbourg
        • Contact:
        • Principal Investigator:
          • Raoul POP
      • Suresnes, France
        • Not yet recruiting
        • Hopital Foch
        • Principal Investigator:
          • Arturo CONSOLI
        • Contact:
      • Toulon, France
        • Not yet recruiting
        • HIA Sainte-Anne
        • Contact:
        • Principal Investigator:
          • Quentin HOLAY
      • Toulouse, France
        • Not yet recruiting
        • CHU de Toulouse
        • Principal Investigator:
          • Christophe COGNARD
        • Contact:
      • Tours, France
        • Not yet recruiting
        • CHRU Tours Hopital Bretonneau
        • Contact:
        • Principal Investigator:
          • Kevin JANOT
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44093
        • Recruiting
        • Nantes University Hospital
        • Contact:
        • Principal Investigator:
          • Romain BOURCIER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria for sporadic ICA cases:

  • 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

Inclusion criteria for index and related cases (familial forms) of intracranial aneurysms (ICA):

  • 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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ICA cases
Any adult patient consulting for a definite and typical bifurcation AIC authenticated on MRI and/or cerebral arteriography
Other: blood or saliva sample
Collection of blood or saliva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance of a predictive model allowing the classification of ICA subphenotypes
Time Frame: 36 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterization of arterial bifurcations
Time Frame: 36 months
Quantitative morphological measurements of arterial bifurcations assessed using image processing tools enabling automatic characterization (artery diameters (in mm); artery cross-sections (in mm²); angles separating arteries (in degrees)
36 months
Characterization of aneurysmal sacs
Time Frame: 36 months
Quantitative morphological measurements of aneurysmal sacs assessed using image processing tools enabling automatic characterization (volume (in mm³); external surface area of the envelope (mm²); neck area (mm²))
36 months
Screening of genetic mutations
Time Frame: 36 months
Presence of genetic mutations in patients with intracranial aneurysms compared with a reference population, but also in a familial context. Genetic variations will be studied by whole exome sequencing
36 months
Correlation between genotypes and phenotypes
Time Frame: 36 months
Correlations between genetic mutations and the different clinical and biological phenotypes described in patients with sporadic ICA
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Collaborators

Federation of Medical Specialties

Investigators

  • Principal Investigator: Romain BOURCIER, MD, Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2025

Primary Completion (Estimated)

March 25, 2027

Study Completion (Estimated)

March 25, 2027

Study Registration Dates

First Submitted

October 31, 2024

First Submitted That Met QC Criteria

November 13, 2024

First Posted (Actual)

November 14, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC24_0512

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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