Not Yet RecruitingNot Applicable

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

Italy196 participantsStarted 2026-01

Plain-language summary

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.

Who can participate

SexALL

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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

What they're measuring

Presence of circulating autoantibodies against SCN5A in plasma of enrolled patients, assessed at baseline (enrollment) and at 6- and 12-month follow-up visits.

Timeframe: Baseline (at enrollment), 6 months, and 12 months.

Trial details

NCT IDNCT07364656

SponsorIRCCS Policlinico S. Donato

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06

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