Analysis of the Presence and Cardiac Functional Effects of Anti-NaV1.5 Autoantibodies in Patients With Metastatic Tumors
1 other identifier
interventional
196
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2026
CompletedFirst Submitted
Initial submission to the registry
January 9, 2026
CompletedFirst Posted
Study publicly available on registry
January 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
January 23, 2026
October 1, 2025
5 months
January 9, 2026
January 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Presence of circulating autoantibodies against SCN5A in plasma of enrolled patients, assessed at baseline (enrollment) and at 6- and 12-month follow-up visits.
The primary outcome of this study is the detection of circulating autoantibodies against the cardiac sodium channel SCN5A in the plasma of enrolled patients. Plasma samples will be collected at baseline, corresponding to study enrollment, and during follow-up visits at 6 and 12 months. The presence or absence of anti-SCN5A autoantibodies will be assessed to evaluate their prevalence and persistence over time and to explore their potential association with disease mechanisms and progression.
Baseline (at enrollment), 6 months, and 12 months.
Study Arms (4)
breast cancer
OTHERmetastatic brest cancer
OTHERcolon cancer
OTHERmetastatic colon cancer
OTHERInterventions
These patients require an ECG to exclude the onset of arrhythmias.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- IRCCS Policlinico S. Donatolead
- IRCCS San Raffaelecollaborator
Study Sites (1)
IRCCS Policlinico San donato
Milan, 20097, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2026
First Posted
January 23, 2026
Study Start
January 1, 2026
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
January 23, 2026
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
De-identified individual participant data including demographic characteristics, clinical variables relevant to the study, and laboratory results related to the presence or absence of anti-SCN5A autoantibodies at baseline, 6-month, and 12-month follow-up assessments.