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Natural History of Familial Cerebral Cavernous Malformations: the CCM_Italia Cohort Study
Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Summary
Patients with symptomatic and asymptomatic familial cerebral cavernous malformation (fCCM) will be included. The goal of this observational study is to learn about the long-term evolution of this condition. The subjects enrolled will be followed for two years and will undergo an annual neurological examination with the recording of clinical events, a brain MRI according to a dedicated protocol, and a blood draw for the determination of circulating biomarkers. They will also be asked to complete questionnaires on quality of life. The data derived from the study will allow for a better understanding of the natural history of the disease and the identification of neuroradiological and/or circulating biomarkers capable of predicting the clinical evolution of the condition.
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2024-11-18
Completion Date
2027-02-28
Last Updated
2025-05-21
Healthy Volunteers
No
Interventions
Cerebral imaging (MRI) according to a dedicated protocol with central MRI reading
Cerebral MRI according to dedicated protocol, central MRI reading.
Determination of circulating biomarkers
High-throughput molecular analysis will be performed on plasma samples collected assessing a selected panel of biomarkers, associated with endothelial cell profiles using automated and high-throughput ELISA. The interactions between mutation profile, protein biomarkers, and clinical variables will be correlated with patients' outcomes.
Locations (6)
Policlinico di Bari
Bari, Italy
Careggi Hospital, Firenze
Florence, Italy
Istituto Giannina Gaslini, Genova
Genova, Italy
Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Milan, Italy
Milan, Italy
Istituto di Ricerche Farmacologiche Mario Negri
Milan, Italy
San Giovanni di Dio e Ruggi d'Aragona", Salerno
Salerno, Italy