Study on Familial Cerebral Cavernous Malformations
Natural History of Familial Cerebral Cavernous Malformations: the CCM_Italia Cohort Study
Recruiting
Observational Study
CCMFamilial Cerebral Cavernous Malformation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Sex
Any
Study type
Observational
Participants needed
100 (estimated)
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Other
Who this trial is looking for
This trial is looking for people with familial cerebral cavernous malformations. Participants will be followed for two years and will have regular check-ups, MRIs, and questionnaires about their quality of life.
Are You a Good Fit for This Trial?
You may be able to join if
I have familial cerebral cavernous malformations confirmed by genetic testing.
I do not have any symptoms, or I have had symptoms related to my condition.
I expect to live at least as long as the study lasts.
I can give written consent to participate.
You may not be able to join if
I have a pacemaker or another device that prevents MRI scans.
I am already in another clinical study.
I am unable to follow study procedures.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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, an…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 defi…
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
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