Clinical trial NCT05526352: @neurIST : Intregrated Biomedical Informatics for the Management of Cerebral Aneurysms
Official title: @neurIST : Informatique biomédicale intégrée Pour la Gestion Des anévrismes cérébraux
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intracranial Aneurysm
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: University of Geneva, Switzerland
name: Klinik Hirslanden, Zurich
First posted: 2022-09-02
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective consecutive recruitment of cases newly diagnosed intracranial aneurysm in each participating clinical center.

Brief summary: The primary aim of the SwissNeuroFoundation AneurysmDataBase Project is to implement information technology based tools to create and use a holistic reference database specific to intracranial aneurysms (IA).

The SwissNeuroFoundation AneurysmDataBase are concerned with generating the data with which to populate this database.

The purpose for populating the database are to:

* Screen for and evaluate markers of risk for intracranial aneurysm formation and aneurysm rupture. Are considered as markers the following: genetics factors, microbiota, environmental factors, congenital factors (ie: cerebrovascular anatomical variants), transcriptomics signature, proteomics signature,shape characteristics, haemodynamics characteristics.
* Screen for and evaluate prognostic factors of outcome regarding different management strategies including watchful observation, microsurgical treatment, endovascular treatment or any combination thereof.
* Implement and evaluate patient-specific management protocols integrating all available information.
* Evaluate the impact of the database and use of tools to improve care, reduce costs, support knowledge discovery and promote new industrial developments.

Detailed description: Clinical history, imaging data, biological samples and information derived from are the main items to be captured to the SwissNeuroFoundation AneurysmDataBase. No limits are set on the number of healthy volunteers and patient cases for whom data can be entered to the SwissNeuroFoundation AneurysmDataBase.

Participants will be recruited from the following sources:

* Patients arriving at partner clinical centers either as newly diagnosed (incidental cases) or already known for the disease (prevalent cases)
* Healthy volunteers answering a call, randomly selected subjects from a known population that consent to participate or non genetically linked family members of patients that consent to participate
* Family members of patients identified as having a familial history of intracranial aneurysm (IA).

Points of consent:

The specific items on which participants are asked to consent:

* to having been verbally informed of the aims of the project
* to having read the information sheet about the project, been able to ask questions about the project, and to having received satisfactory answers and enough time to make the decision.
* to having been informed that any damage that could be directly caused by the participation to the project is covered by insurance.
* that hospital care providers working on behalf of the project and representatives of the local authorities and ethics commission may access in a strictly confidential term raw data for quality check.
* to having been informed that participation can be withdrawn anytime without justification and will result in a medical assessment for own security. There will be no impact on future care resulting from withdrawal.
* to be free to refuse answering questions without requiring any justification and it will have no impact on future care.
* to understand that data may be used in a non-identifying form for publication.
* to understand that data provided may form part of future commercial applications, and will not benefit financially from this.
* to understand and agree that coded data may be used for further cerebrovascular-related research.
* that they understand that coded data about them or biological samples may be transferred outside the European Union.

The specific items on which participants are asked to agree or disagree:

* that they agree to provide access to health records, to provide a link from them to the SwissNeuroFoundation AneurysmDataBase, and to complete a questionnaire on their clinical history.
* give agreement to provide image data to SwissNeuroFoundation AneurysmDataBase.
* give agreement to provide blood samples to SwissNeuroFoundation AneurysmDataBase.
* give agreement to use biological samples resulting from therapeutical intervention.
* give agreement to use saliva and stool samples to SwissNeuroFoundation AneurysmDataBase.
* give agreement to be re-contacted by SwissNeuroFoundation AneurysmDataBase for further consent or to request further information.
* give agreement to inform the General Practitioner about the participation to the project.
* give agreement to contact the General Practitioner to request information on participant whereabouts or limited relevant medical information, if direct contact was unsuccessful during 3 months.
* request to be informed by the clinician in charge about observations resulting from the project that may have a significant impact on the participant health.
* request the General Practitioner of the participant to be informed about observations resulting from the project that may have a significant impact on the participant health.

Separate specific points of consent relative to biological samples and genetics:

* having read the genetic testing information sheet, been able to ask questions about genetic testing, and understanding why the research is being done and any risks involved
* give agreement to provide blood samples to SwissNeuroFoundation AneurysmDataBase
* understanding that genetic data arising from samples may form part of future commercial applications, and that they will not benefit financially from this.
* understanding that they are free to withdraw at any time and may ask for their sample to be destroyed then, or at any other time.
* agree that blood samples be stored and used for genetic analysis.
* agree that blood, aneurysm dome, cerebrospinal fluid (CSF) and microdialysis samples be stored and used for further cerebrovascular-related research.
* agreement that blood samples may be transferred with coded labels to other Universities in the World.

For the purpose of the AneurysmDataBase:

Clinical Information consists of:

* Demographic information (Pseudonym, Age, Gender, Size, Weight, work and sport activities, habits: smoking, alcool consumption).
* Personal medical history (Previous strokes, previous epilepsy, previous medication)
* Family tree denoting known or likely diagnosed IA or subarachnoid hemorrhage (SAH) events.
* Signs and symptoms (date of ictus, date of diagnosis, mRankin score, Glasgow Coma Scale (GCS), NIH Stroke Scale (NIHSS),Mini Mental State Exam (MMSE), World Federation of Neurosurgeons Scale WFNS, Cranial nerve deficits)
* Identified epidemiology factors according to check list.
* Imaging analysis (Presence of SAH, Fisher grade, size of ventricles, size of basal cisterns, volume of hematoma and location, number of aneurysms, location of aneurysms, size of aneurysms, shape of aneurysm)
* Treatment and outcome information (treatment method, success)
* Follow-up and outcome information (Quality of life assessment, MMSE, mRankin, NIHSS, Cranial nerve deficits, aneurysms status: stable, growth, treated, partially treated)

Imaging Data consist of:

* Pseudonymised DICOM files of:
* MRI angiography (MRA)
* Computed Tomography Angiography (CTA)
* 3D reconstruction of Digital Rotation Angiography (3D-DRA)

Samples consist of:

* Blood in DNA saving solution
* Blood in RNA saving solution
* Blood in EDTA
* CSF
* Aneurysm dome
* Saliva
* Stool
* Other biological sample to be specified

Eligibility criteria: Inclusion Criteria:

* able to provide consent or, in the event that a patient is incapable of providing consent, that a person is legally authorized to do so on behalf of the patient according to legal and ethical requirements of the country where the clinical centre is located.

Patients:

* must have an angiographically proven intracranial aneurysm (MRA\< CTA\< DSA accepted).The determination of SAH requires the presence of a subarachnoid haemorrhage be verified on CT or by lumbar puncture.

MRA: Magnetic Resonance Angiography CTA: Computed Tomography Angiography DSA: Digital Subtracted Angiography

Exclusion Criteria:

* failure of a candidate to contribute clinical data,
* refusal to provide informed consent.

Primary outcomes:
measure: Disease model validation
timeFrame: 5 years
Secondary outcomes:
measure: Life expectancy
timeFrame: 20 years
measure: Disability
timeFrame: 20 years
measure: Cure
timeFrame: 20 years
measure: Adverse events
timeFrame: 20 years
measure: Aneurysm growth
timeFrame: 20 years
measure: Radiological aneurysm exclusion
timeFrame: 20 years
measure: Recurrence
timeFrame: 20 years
measure: Neo-aneurysm formation
timeFrame: 20 years
measure: Quality of life
timeFrame: 20 years
measure: Neuropsychological performance
timeFrame: 20 years
measure: Neurological status
timeFrame: 20 years
measure: Cranial nerves status
timeFrame: 20 years
measure: Occurence of hydrocephalus
timeFrame: 20 years
measure: Occurence of vasospasm
timeFrame: 20 years
measure: Delayed Cerebral Injury (DCI)
timeFrame: 20 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California
state: California
city: Cincinnati
country: United States
facility: University of Cincinnati College of Medicine
state: Ohio
city: Virginia Beach
country: United States
facility: University of Virginia
state: Virginia
city: Montréal
country: Canada
facility: Montreal Neurological Institute and Hospital, McGill University
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Nantes
country: France
facility: ICAN
city: Munich
country: Germany
facility: Department of Neurosurgery, Klinikum rechts der Isar, Technical University Munich
city: Pécs
country: Hungary
facility: University of Pecs
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Cracovia
country: Poland
facility: Jagiellonian University Medical College
city: Barcelona
country: Spain
facility: Barcelona Hospital General de Cataluna
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Barcelona
country: Spain
facility: IMIM - Hospital del Mar
city: Geneva
country: Switzerland
facility: Neurochirurgie / Hôpitaux Universitaire de Genève
city: Saint Gallen
country: Switzerland
facility: Department of Neurosurgery, Cantonal Hospital St. Gallen
city: Zürich
country: Switzerland
facility: Klinik Hirslanded
city: London
country: United Kingdom
facility: University College London
city: Oxford
country: United Kingdom
facility: Radcliffe Infirmary
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
Study officials:
affiliation: Geneva University
name: Philippe Bijlenga, PD MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpitaux Universitaire de Genève
name: Sandrine Morel, PD PhD
role: STUDY_CHAIR
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