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

Sponsor
IRCCS Policlinico S. Donato
Study ID
NCT07364656
Status
Not Yet Recruiting

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Conditions

  • Autoantibodies Screening
  • Breast Cancer Females
  • Brugada Syndrome (BrS)
  • Colon Cancer
  • ECG Abnormalities

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

First listed
Jan 23, 2026
Start date
Jan 31, 2026
Status verified
Oct 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
196 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Other: breast cancer
  • Other: metastatic brest cancer
  • Other: colon cancer
  • Other: metastatic colon cancer

Primary Outcome Measure

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. ]

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