NCT06983132 Natural History of Familial Cerebral Cavernous Malformations: the CCM_Italia Cohort Study
| NCT ID | NCT06983132 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
| Condition | CCM |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-11-18 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-11-18 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06983132 clinical trial?
This trial is open to participants of all sexes, studying CCM. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06983132 currently recruiting?
Yes, NCT06983132 is actively recruiting participants. Contact the research team at silvia.lanfranconi@policlinico.mi.it for enrollment information.
Where is the NCT06983132 trial being conducted?
This trial is being conducted at Bari, Italy, Florence, Italy, Genova, Italy, Milan, Italy and 2 additional locations.
Who is sponsoring the NCT06983132 clinical trial?
NCT06983132 is sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. The trial plans to enroll 100 participants.