Analysis of the Presence and Cardiac Functional Effects of Anti-NaV1.5 Autoantibodies in Patients With Metastatic Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ECG.
- Who it may be relevant to
- Registry conditions: Brugada Syndrome (BrS), Breast Cancer Females, Colon Cancer, ECG Abnormalities. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test ECG
These patients require an ECG to exclude the onset of arrhythmias.
Primary outcome measures
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Italy · 1 center
- IRCCS Policlinico San donato — Milan
Identifiers
NCT: NCT07364656 · NAV-CARD