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

San Donato Group (GSD)

Status: Not yet enrolling

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

Treatments: Diagnostic Test: ECG

Study type: Interventional

Funder types: Other

Identifiers

NCT07364656

NAV-CARD

Details and patient eligibility

About

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.

Enrollment: 196 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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196 participants in 4 patient groups

breast cancer

Other group

Treatment:

Diagnostic Test: ECG

metastatic brest cancer

Other group

Treatment:

Diagnostic Test: ECG

colon cancer

Other group

Treatment:

Diagnostic Test: ECG

metastatic colon cancer

Other group

Treatment:

Diagnostic Test: ECG