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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorIRCCS Policlinico S. Donato

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

Sponsors and collaborators

IRCCS Policlinico S. Donato

Lead sponsor

IRCCS San Raffaele

Collaborator