CADASILB-MRVC2NCT07650110
Biological Collection of the Rare Diseases of the Brain and Eye Vessels Cohort - 2
A study testing Biocollection and Neurological evaluation and Biocollection in people with CADASIL and Cavernous Angioma, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
CERVCO is the French National Reference Centre for Rare Cerebrovascular and Retinal Diseases, accredited by the Ministry of Health since 2005. Since 2017, CERVCO has coordinated the MRVC cohort, a prospective cohort of patients with rare vascular diseases of the brain and retina, and established the associated B-MRVC… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- CADASIL, Cavernous Angioma, Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy
- What is being tested?
- Biocollection and Neurological evaluation and Biocollection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2026to 30 Jun 2038
- Phase
- Interventional
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For the group of patients with MVCR:
- Patients aged between 18 and 80 years at the time of inclusion
- Diagnosis confirmed by the detection of a pathogenic mutation in the NOTCH3 gene characteristic of CADASIL, or in another gene responsible for other forms of monogenic cSVD (such as the COL4A1, COL4A2 and HTRA1 genes) or a confirmed diagnosis of MOYA-MOYA (arteriography and/or genetic testing) or cavernoma, cerebral venous thrombosis or a cerebral vascular malformation, including cavernomas
- Covered by social security or an equivalent scheme
- Written consent.
- Patient included in the MVCR cohort For control group
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- Subject aged between 18 and 80 at the time of inclusion.
- Written consent.
- Blood pressure < 140/90 mmHg without treatment or < 130/80 mmHg if treated and stable for ≥3 months
- Covered by social security or a similar scheme
- Strictly normal neurological examination (NIHSS=0; no focal deficit)
- Normal cognitive examination: MMSE ≥ 26
Who cannot join
- Common exclusion criteria for patients and control subjects:
- A person referred to in Articles L. 1121-5 to L. 1121-8 and L. 1122-12 of the Public Health Code, defined as:
- Pregnant women, women in labour or breastfeeding women
- Persons deprived of their liberty by judicial or administrative decision
- Persons hospitalised without consent and not subject to a legal protection measure, and persons admitted to a health or social care facility for purposes other than research
- Minors
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- Adults subject to a legal protection measure (guardianship, curatorship or judicial protection), adults unable to give consent and not subject to a legal protection measure
- Individuals subject to a withdrawal period for another research study
- Patients participating in another interventional research study
- Acute or chronic infectious disease
- Specific exclusion criteria for control subjects
- Any identified extra- or intracranial vascular pathology requiring specific management
- Known cardiovascular disease (coronary artery disease, arterial disease, atrial fibrillation, heart failure)
- Neurological history: stroke, TIA, intracranial haemorrhage, meningitis/encephalitis, head injury with loss of consciousness >30 mins,
- Multiple sclerosis, neurodegenerative disease, active epilepsy,
- Current or former smoking (more than 10 pack-years)
- Diabetes
- Antithrombotic or lipid-lowering treatment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Collection Biologique de la Cohorte Des Maladies Rares Des Vaisseaux du Cerveau et de l'œil - 2
CERVCO is the French National Reference Centre for Rare Cerebrovascular and Retinal Diseases, accredited by the Ministry of Health since 2005. Since 2017, CERVCO has coordinated the MRVC cohort, a prospective cohort of patients with rare vascular diseases of the brain and retina, and established the associated B-MRVC biobank in 2020 to support translational research and biomarker discovery.
Due to the rarity and heterogeneity of these disorders, centralized longitudinal collection of clinical data and biological samples is essential to improve understanding of disease mechanisms, identify biomarkers of progression and prognosis, and facilitate the development of new diagnostic and therapeutic approaches.
The present study aims to expand this longitudinal biobank, enable national and international collaborative research through controlled sample sharing, and establish reference control samples to support biomarker validation.
- Conditions
- CADASIL, Cavernous Angioma, Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy, Small Vessel Disease
- Being tested
- Biocollection, Neurological evaluation and Biocollection
- Keywords
- Brain Small Vessel Disease, Cadasil, Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy, Central Nervous System Vascular Malformations, Cavernous Angioma, Central Nervous System
- Medical subject headings
- CADASIL, Hemangioma, Cavernous, Central Nervous System Vascular Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiocollectionOther
Additional blood collection
Neurological evaluation and BiocollectionOther
For healthy volunteers: neurological evaluation, blood and urine sampling
| Study group | Role | What they receive |
|---|---|---|
| MVCR patients | Other | Patient with a confirmed diagnosis of rare cerebro-vacular disease Receives: Other: Biocollection |
| Control group | Other | Healthy controls / volunteers s with no cardiovascular or neurovascular disease Receives: Other: Neurological evaluation and Biocollection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparative analysis of proteins
Comparative analysis of proteins and candidate biomarkers in serum or plasma between patients with a rare brain disorder and control subjects
Measured: At inclusion
Secondary outcomes (5)
Measurement of proteins and biomarkers
Measured: Up to 5 years
Occurrence of a significant event indicating disease progression
Stroke, cognitive decline, progressive markers in brain or retinal imaging
Measured: Up to 5 years
Inter-method variability of assays assessed by measures of agreement between techniques
Measured: Up to 5 years
Protein/biomarker assays according to the different conditions involved
Measured: Up to 5 years
Protein/biomarker assays according to sex and age
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 Jun 2038 (estimated)
- Study completion30 Jun 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CADASILStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A single-centre, non-randomised prospective biobanking study, conducted as an ancillary component of the MVCR cohort study
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07650110
- Sponsor's protocol ID
- APHP260095
- Acronym
- B-MRVC2
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided