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Recruiting NCT06689410

Multimodal Biocollection Linked to the French Register of Intracranial Aneurysms

No phase Interventional Aneurysm Brain Aneurysm Congenital Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: blood or saliva sample.
Who it may be relevant to
Registry conditions: Aneurysm, Brain Aneurysm, Congenital Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other blood or saliva sample
    Collection of blood or saliva

Primary outcome measures

  • Performance of a predictive model allowing the classification of ICA subphenotypes [Time frame: 36 months]
Secondary outcome measures (4)
  • Characterization of arterial bifurcations [Time frame: 36 months]
  • Characterization of aneurysmal sacs [Time frame: 36 months]
  • Screening of genetic mutations [Time frame: 36 months]
  • Correlation between genotypes and phenotypes [Time frame: 36 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 26 centers
  • Nantes University Hospital — Nantes
  • CHU Amiens — Amiens
  • CHU Angers — Angers
  • CHU Besançon — Besançon
  • CHU Bordeaux Hôpital Pellegrin — Bordeaux
  • CHU de Brest — Brest
  • CHU Caen-Normandie — Caen
  • CHU Clermont-Ferrand — Clermont-Ferrand
  • … and 18 more centers

Identifiers

NCT: NCT06689410 · RC24_0512

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗