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

Starting soon · Not applicable

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

In brief

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.

Key facts

Study ID

NCT07364656

Run by

IRCCS Policlinico S. Donato

People needed

196

Starts

2026-01-01

Expected to finish

2026-12-01

Last updated by the study team

2026-01-23

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• IRCCS Policlinico San donato — Milan, Italy

Full record on ClinicalTrials.gov

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