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Natural History of Familial Cerebral Cavernous Malformations: the CCM_Italia Cohort Study

Recruitingn/aAges any - anyAllFondazione IRCCS Ca' Granda, Ospedale Maggiore Po…
NCT06983132 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • Cerebral imaging (MRI) according to a dedicated protocol with central MRI reading
  • Determination of circulating biomarkers
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Where

6 sites
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
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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