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

Recruiting now

Conditions studied: CCM, Familial Cerebral Cavernous Malformation

In brief

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 facts

Study ID

NCT06983132

Run by

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

People needed

100

Starts

2024-11-18

Expected to finish

2027-02-28

Last updated by the study team

2025-05-21

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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.

Where it is running

• Careggi Hospital, Firenze — Florence, Italy (enrolling)
• Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Milan, Italy — Milan, Italy (enrolling)
• San Giovanni di Dio e Ruggi d'Aragona", Salerno — Salerno, Italy (enrolling)
• Policlinico di Bari — Bari, Italy
• Istituto Giannina Gaslini, Genova — Genova, Italy
• Istituto di Ricerche Farmacologiche Mario Negri — Milan, Italy

Full record on ClinicalTrials.gov

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