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

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.

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Key information

Conditions

Brugada Syndrome (BrS) Arrhythmias, Cardiac Autoantibodies Screening Breast Cancer Females Brugada Syndrome Cardiac Conduction System Disease Cardiovascular Diseases Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Digestive System Neoplasms ECG Abnormalities Gastrointestinal Diseases Gastrointestinal Neoplasms Genetic Diseases, Inborn Heart Diseases Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Policlinico San donato

Milan, 20097, Italy

Location contact

Carlo Pappone, Dr.

CONTACT

[email protected]

0252774260

Carlo Pappone, Dr.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ECG

Diagnostic Test

These patients require an ECG to exclude the onset of arrhythmias.

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.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

IRCCS Policlinico S. Donato

Other

Collaborators

IRCCS San Raffaele

Registry information

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jan 23, 2026
Registry last updated: Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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