Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05526352 |
| Other study ID # |
CCER 2022-00426 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2015 |
| Est. completion date |
March 1, 2040 |
Study information
| Verified date |
November 2023 |
| Source |
University Hospital, Geneva |
| Contact |
Sven Hirsch, Dr |
| Phone |
+41 58 934 54 44 |
| Email |
hirc[@]zhaw.ch |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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
