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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Policlinico di Bari
NOT_YET_RECRUITING
Bari
Careggi Hospital, Firenze
RECRUITING
Florence
Istituto Giannina Gaslini, Genova
NOT_YET_RECRUITING
Genova
Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Milan, Italy
RECRUITING
Milan
Istituto di Ricerche Farmacologiche Mario Negri
ACTIVE_NOT_RECRUITING
Milan
San Giovanni di Dio e Ruggi d'Aragona, Salerno
RECRUITING
Salerno
Contact Information
Primary
Silvia Lanfranconi, MD, Neurologist
silvia.lanfranconi@policlinico.mi.it
+390255033802
Time Frame
Start Date: 2024-11-18
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 100
Treatments
Patients with symptomatic and asymptomatic familial cerebral angiomatosis will be included.
Patients with symptomatic and asymptomatic familial cerebral angiomatosis will be included. Subjects without genetic diagnosis will not be included. Other exclusion ctiteria will be current inclusion in a different clinical study, inability to cooperate with study procedures, contraindication to cerebral MRI.
Sponsors
Collaborators: Azienda Ospedaliero-Universitaria Careggi, Istituto Giannina Gaslini, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, University of Bari, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona, Mario Negri Institute for Pharmacological Research
Leads: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

This content was sourced from clinicaltrials.gov