Autoantibodies Screening, Breast Cancer Females, Brugada Syndrome (BrS), Colon Cancer, ECG Abnormalities
Conditions
Brief summary
The overall aim of this study is to identify and characterize anti-NaV1.5 autoantibodies in patients with metastatic breast and colorectal cancer. These tumors are characterized by the presence of a specific target structure (called nNaV1.5) against which antibodies are produced. These antibodies may cross-react with a similar structure (called NaV1.5) that is found in the heart. This could affect channel function and increase the risk of arrhythmias.
Interventions
DIAGNOSTIC_TESTECG
These patients require an ECG to exclude the onset of arrhythmias.
Sponsors
IRCCS Policlinico S. Donato
IRCCS San Raffaele
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Patients with a confirmed diagnosis of breast or colorectal cancer, either metastatic or non-metastatic * Patients already receiving first-line therapy with a confirmed diagnosis of breast or colorectal cancer, either metastatic or non-metastatic * Signed informed consent
Exclusion criteria
* Clinically significant cardiovascular diseases (atrial fibrillation, congestive heart failure, cardiomyopathies, or inherited arrhythmic syndromes) * Known autoimmune diseases or immunodeficiencies * Use of high-dose immunosuppressive drugs or other experimental treatments that could interfere with the assessment of study endpoints
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of circulating autoantibodies against SCN5A in plasma of enrolled patients, assessed at baseline (enrollment) and at 6- and 12-month follow-up visits. | Baseline (at enrollment), 6 months, and 12 months. | The primary outcome of this study is the detection of circulating autoantibodies against the cardiac sodium channel SCN5A in the plasma of enrolled patients. Plasma samples will be collected at baseline, corresponding to study enrollment, and during follow-up visits at 6 and 12 months. The presence or absence of anti-SCN5A autoantibodies will be assessed to evaluate their prevalence and persistence over time and to explore their potential association with disease mechanisms and progression. |
Countries
Italy
Outcome results
None listed