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Not yet recruitingNCT07650110B-MRVC2Updated Jun 16, 2026

Biological Collection of the Rare Diseases of the Brain and Eye Vessels Cohort - 2

An interventional study of Biocollection and Neurological evaluation and Biocollection in CADASIL, Cavernous Angioma and Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • CADASIL
  • Cavernous Angioma
  • Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy
  • Small Vessel Disease

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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
03

In context

CADASIL

33 studies on the registry are indexed under CADASIL; 18 are open to participants now.

This study's planned enrollment of 600 is above the median of 60 across 10 interventional studies indexed under CADASIL.

Browse CADASIL studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.

Browse Assistance Publique - Hôpitaux de Paris studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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
  • 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: ≥ 26

Exclusion criteria

Exclusion criteria :

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
    • 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, , 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
600 participants (estimated)

Study arms

  • Other
    MVCR patients

    Patient with a confirmed diagnosis of rare cerebro-vacular disease

    Other: Biocollection

  • Other
    Control group

    Healthy controls / volunteers s with no cardiovascular or neurovascular disease

    Other: Neurological evaluation and Biocollection

Interventions

  • OtherBiocollection

    Additional blood collection

  • OtherNeurological evaluation and Biocollection

    For healthy volunteers: neurological evaluation, blood and urine sampling

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: At inclusion

Secondary outcomes

  1. Measurement of proteins and biomarkers

    Time frame: Up to 5 years

  2. Occurrence of a significant event indicating disease progression

    Stroke, cognitive decline, progressive markers in brain or retinal imaging

    Time frame: Up to 5 years

  3. Inter-method variability of assays assessed by measures of agreement between techniques

    Time frame: Up to 5 years

  4. Protein/biomarker assays according to the different conditions involved

    Time frame: Up to 5 years

  5. Protein/biomarker assays according to sex and age

    Time frame: Up to 5 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jun 2026; primary completion for Jun 2038, 144 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 10, 2026
First posted
Jun 16, 2026
StartEst.
Jun 30, 2026
Primary completionEst.
Jun 30, 2038
CompletionEst.
Jun 30, 2038
Last update
Jun 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07650110
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Jun 16, 2026
Start date
Jun 30, 2026 (estimated)
Primary completion
Jun 30, 2038 (estimated)
Completion
Jun 30, 2038 (estimated)
Last update
Jun 16, 2026

Study contacts

Hugues Chabriat, MD PhD
Contact
hugues.chabriat@aphp.fr
+33 1 49 95 25 93 ext. +33
Jérôme Lambert
Contact
jerome.lambert@u-paris.fr
+33 1 42 49 97 42 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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