About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Treatments tested in this trial

  • ECG

Treatment groups

196 Participants
are divided into 4 treatment groups

Locations

1
IRCCS Policlinico San donato20097, Milan Italy

Sponsors and collaborators

IRCCS Policlinico S. Donato

Lead sponsor

IRCCS San Raffaele

Collaborator