Intracranial AneurysmI-CANNCT02712892
I-CAN Biocollection
An observational study of Intracranial Aneurysm, run by Nantes University Hospital at 20 sites in France.
Trial summary
Intracranial aneurysm (IA) is an asymptomatic cerebrovascular abnormality affecting 3.2% of the general population. The devastating complication of IA is its rupture, resulting in subarachnoid haemorrhage that can lead to severe disability and death. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Non Interventional Study
- How many people
- 3,078 participants
- Where
- 20 sitesFrance
- Study dates
- 3 Mar 2016to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The initial stage of this biocollection based on the recruitment of large families for genetic linkage analysis. This is a first step to identify patients with intracranial aneurysms occurring in a family context, and to conduct a comprehensive investigation according to clinical guidelines in force to assess the potentially informative family and ensure their adherence to the prior biocollection. The next step is the fine and accurate phenotyping of each of the family members (imaging) and the collection of a blood sample for DNA extraction for molecular genetic analysis. The population recruited will be composed of index and their healthy relatives and cases with sporadic cases and IA. The kinship links will be established from family trees.
Who may be able to join
- Any patient consulting for IA and some typical bifurcation
- Patients aged 20 years or older
- biocollection of Written Consent for participation in the collection of biological samples
- Non Inclusion Criteria:
- Patients who have shown the inability or refusal to sign the consent informed biocollection
- syndromic diagnosis known as AIC provider
Show all 18Show fewer
- Marfan Syndrome
- AOS with SMAD 3
- Danlos Syndrome Elhers type II and IV
- Autosomal Dominant Polycystic
- Moyamoya Syndrome
- character of IA:
- Dissecting or fusiform
- Combined with an arteriovenous malformation
- Blister-like
- mycotic
- Pathology of the cerebral white matter detected on MRI suggestive:
- Mutation COL4A1
Who cannot join
None listed.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
France20 sites
Angers University Hospital
Angers, 49933
Besançon University Hospital
Besançon, 25030
Bordeaux University Hospital
Bordeaux, 33404
Henri Mondor Hospital (AP-HP)
Créteil, 94000
Dijon University Hospital
Dijon, 21079
Grenoble University Hospital
Grenoble, 38043
La Reunion University Hospital
La Réunion, 97448
Kremlin-Bicêtre University Hospital (AP-HP)
Le Kremlin-Bicêtre, 94270
Limoges University Hospital
Limoges, 87042
Nancy University Hospital
Nancy, 54035
Nantes University Hospital
Nantes, 44093
Lariboisière University Hospital (AP-HP)
Paris, 75010
La Pitié-Salpétrière University Hospital (AP-HP)
Paris, 75013
Sainte Anne Hospital
Paris, 75014
Rotschild Fundation
Paris, 75019
Poitiers University Hospital
Poitiers, 86021
Rennes University Hospital
Rennes, 35033
Rouen University Hospital
Rouen, 76031
Toulouse University Hospital
Toulouse, 31059
Tours University Hospital
Tours, 37044
About this study
Official title: IntraCranial ANeurysms: From Familial Forms to Pathophysiological Mechanisms
Intracranial aneurysm (IA) is an asymptomatic cerebrovascular abnormality affecting 3.2% of the general population. The devastating complication of IA is its rupture, resulting in subarachnoid haemorrhage that can lead to severe disability and death. Unfortunately, there are neither reliable clues nor diagnostic tools to predict the formation and/or the fate of an IA in a given individual. Also, there is no pharmacological drug available to prevent the rupture of aneurysm and subsequent subarachnoid haemorrhage. Current treatments are invasive with a significant risk of procedural morbidity. Thus, still now, the management of patients with IA remains extremely challenging and still controversial. Although the pathogenesis of IA has been the subject of many studies for the last decade, the mechanisms underlying IA formation, growth and rupture are still mostly unknown and relevant animal models of IA are not available. Familial history of IA predisposes to IA formation and rupture and increasing evidence suggest a genetic component of IA formation, with heterogeneous modes of inheritance and penetrance. This project, gathering neuroradiologists, geneticists and vascular biologists, addresses the urgent need to understand the pathogenic mechanisms of IA to develop diagnostic and predictive tools of risk of IA. The investigators propose to identify IA-causing variants by whole-exome sequencing in familial forms of the disease. The investigators hypothesises that the functional analysis of the causal/susceptibility variants thus identified will provide clues to understanding the pathological mechanisms of IA formation, and the bases for developing diagnostic tools. This project aims at meeting this challenge. Based on preliminary data that already allowed to identify such a variant, and the combination of genetic and functional investigations, the specific objectives of this project are: - To identify IA-causing variants in familial forms of the disease by whole-exome sequencing; - To understand the function of these genes/variants in the formation and rupture of IA by molecular and cellular approaches and generation of relevant animal models; - To discover potential biomarkers of risk of IA formation and/or rupture.
- Conditions
- Intracranial Aneurysm
- Being tested
- Non Interventional Study
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non Interventional StudyGenetic
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of genetic abnormalitie
Identification of genetic abnormalities segregant with the presence of intracranial aneurysms in the informative families recruited. Sequencing of the whole exome in a cohort of patients carriers of familial forms of intracranial aneurysms.
Analysis of blood level of the GAIA 1 protein in a large cohort of familial and sporadic carriers of intracranial aneurysms
Measured: Until one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study start3 Mar 2016
- Primary completion19 Dec 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 3,078 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hubert DESAL, Pr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712892
- Sponsor's protocol ID
- RC15_0304
- Acronym
- I-CAN
- Status last verified
- Sep 2021
- First submitted
- 23 Feb 2016
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
L'Allinec V, Chatel S, Karakachoff M, Bourcereau E, Lamoureux Z, Gaignard A, Autrusseau F, Jouan S, Vion AC, Loirand G, Desal H, Naggara O, Redon R, Edjlali M, Bourcier R. Prediction of Unruptured Intracranial Aneurysm Evolution: The UCAN Project. Neurosurgery. 2020 Jul 1;87(1):150-156. doi: 10.1093/neuros/nyaa093.
PubMed 32374868
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IntraCranial ANeurysms: From Familial Forms to Pathophysiological Mechanisms
- ClinicalTrials.gov ID
- NCT02712892
- Acronym / sponsor ID
- I-CAN / RC15_0304
- Conditions
- Intracranial Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,078 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 3 Mar 2016 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 18 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intracranial aneurysm (IA) is an asymptomatic cerebrovascular abnormality affecting 3.2% of the general population. The devastating complication of IA is its rupture, resulting in subarachnoid haemorrhage that can lead to severe disability and death. Unfortunately, there are neither reliable clues nor diagnostic tools to predict the formation and/or the fate of an IA in a given individual. Also, there is no pharmacological drug available to prevent the rupture of aneurysm and subsequent subarachnoid haemorrhage. Current treatments are invasive with a significant risk of procedural morbidity. Thus, still now, the management of patients with IA remains extremely challenging and still controversial. Although the pathogenesis of IA has been the subject of many studies for the last decade, the mechanisms underlying IA formation, growth and rupture are still mostly unknown and relevant animal models of IA are not available. Familial history of IA predisposes to IA formation and rupture and increasing evidence suggest a genetic component of IA formation, with heterogeneous modes of inheritance and penetrance. This project, gathering neuroradiologists, geneticists and vascular biologists, addresses the urgent need to understand the pathogenic mechanisms of IA to develop diagnostic and predictive tools of risk of IA. The investigators propose to identify IA-causing variants by whole-exome sequencing in familial forms of the disease. The investigators hypothesises that the functional analysis of the causal/susceptibility variants thus identified will provide clues to understanding the pathological mechanisms of IA formation, and the bases for developing diagnostic tools. This project aims at meeting this challenge. Based on preliminary data that already allowed to identify such a variant, and the combination of genetic and functional investigations, the specific objectives of this project are: - To identify IA-causing variants in familial forms of the disease by whole-exome sequencing; - To understand the function of these genes/variants in the formation and rupture of IA by molecular and cellular approaches and generation of relevant animal models; - To discover potential biomarkers of risk of IA formation and/or rupture.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The initial stage of this biocollection based on the recruitment of large families for genetic linkage analysis. This is a first step to identify patients with intracranial aneurysms occurring in a family context, and to conduct a comprehensive investigation according to clinical guidelines in force to assess the potentially informative family and ensure their adherence to the prior biocollection. The next step is the fine and accurate phenotyping of each of the family members (imaging) and the collection of a blood sample for DNA extraction for molecular genetic analysis. The population recruited will be composed of index and their healthy relatives and cases with sporadic cases and IA. The kinship links will be established from family trees.
Key inclusion criteria (18 listed)
- Any patient consulting for IA and some typical bifurcation
- Patients aged 20 years or older
- biocollection of Written Consent for participation in the collection of biological samples
- Patients who have shown the inability or refusal to sign the consent informed biocollection
- syndromic diagnosis known as AIC provider
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non Interventional Study | Genetic | – |
Primary outcome
Presence or absence of genetic abnormalitie
Time frame: Until one year
Identification of genetic abnormalities segregant with the presence of intracranial aneurysms in the informative families recruited. Sequencing of the whole exome in a cohort of patients carriers of familial forms of intracranial aneurysms. Analysis of blood level of the GAIA 1 protein in a large cohort of familial and sporadic carriers of intracranial aneurysms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Derived from this study: PubMed 32374868L'Allinec V, Chatel S, Karakachoff M, Bourcereau E, Lamoureux Z, Gaignard A, Autrusseau F, Jouan S, Vion AC, Loirand G, Desal H, Naggara O, Redon R, Edjlali M, Bourcier R. Prediction of Unruptured Intracranial Aneurysm Evolution: The UCAN Project. Neurosurgery. 2020 Jul 1;87(1):150-156. doi: 10.1093/neuros/nyaa093.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hubert DESAL, Pr principal investigator
Nantes University Hospital
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm, run by Nantes University Hospital at 20 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of genetic abnormalitie (time frame: Until one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02712892, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.