Analysis of the Presence and Cardiac Functional Effects of Anti-NaV1.5 Autoantibodies in Patients With Metastatic Tumors

N/ANot Yet RecruitingNCT07364656

IRCCS Policlinico S. Donato196 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

196

Conditions

Brugada Syndrome (BrS)Breast Cancer Females Colon Cancer ECG Abnormalities Autoantibodies Screening

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Presence of circulating autoantibodies against SCN5A in plasma of enrolled patients, assessed at baseline (enrollment) and at 6- and 12-month follow-up visits.

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.

Time frame: Baseline (at enrollment), 6 months, and 12 months.