Status:
RECRUITING
Natural History of Familial Cerebral Cavernous Malformations: the CCM_Italia Cohort Study
Lead Sponsor:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Collaborating Sponsors:
Mario Negri Institute for Pharmacological Research
Istituto Giannina Gaslini
Conditions:
CCM
Familial Cerebral Cavernous Malformation
Eligibility:
All Genders
Brief 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 cond...
Detailed Description
CCM\_Italia is an observational non interventional national multicentric registry. Patients will be enrolled prospectively and followed for a 2 years period through annual neurological evaluation, ce...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 18 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 28 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06983132
Start Date
November 18 2024
End Date
February 28 2027
Last Update
May 21 2025
Active Locations (6)
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1
Policlinico di Bari
Bari, Italy, 70124
2
Careggi Hospital, Firenze
Florence, Italy
3
Istituto Giannina Gaslini, Genova
Genova, Italy
4
Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Milan, Italy
Milan, Italy, 20122