Actively Recruiting
Natural History of Familial Cerebral Cavernous Malformations: the CCM_Italia Cohort Study
Led by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Updated on 2025-05-21
100
Participants Needed
6
Research Sites
118 weeks
Total Duration
On this page
Sponsors
F
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Lead Sponsor
M
Mario Negri Institute for Pharmacological Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Natural History of Familial Cerebral Cavernous Malformations: the CCM_Italia Cohort Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with familial cerebral cavernous malformations (FCCM), documented by mutations in the CCM1, CCM2, or CCM3 genes
- Asymptomatic patients or those with a history of clinical symptoms or events, such as intracerebral hemorrhage, stroke, permanent or transient focal deficits, seizures, disability, or any other neurological symptom presumably related to CCM
- Life expectancy at least equal to the duration of the study follow-up
- Written informed consent from the patient (or guardian in the case of minors) to participate in the study
You will not qualify if you...
- Implanted pacemaker or any other condition that precludes magnetic resonance imaging
- Participation in another ongoing interventional clinical study
- Inability to cooperate with the study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Policlinico di Bari
Bari, Italy, 70124
Not Yet Recruiting
2
Careggi Hospital, Firenze
Florence, Italy
Actively Recruiting
3
Istituto Giannina Gaslini, Genova
Genova, Italy
Not Yet Recruiting
4
Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Milan, Italy
Milan, Italy, 20122
Actively Recruiting
5
Istituto di Ricerche Farmacologiche Mario Negri
Milan, Italy, 20256
Active, Not Recruiting
6
San Giovanni di Dio e Ruggi d'Aragona", Salerno
Salerno, Italy
Actively Recruiting
Research Team
S
Silvia Lanfranconi, MD, Neurologist
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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