Brugada Syndrome (BrS)NCT07364656
Analysis of the Presence and Cardiac Functional Effects of Anti-NaV1.5 Autoantibodies in Patients With Metastatic Tumors
A study testing ECG in people with Brugada Syndrome (BrS) and Breast Cancer Females, run by IRCCS Policlinico S. Donato at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brugada Syndrome (BrS), Breast Cancer Females, Colon Cancer
- What is being tested?
- ECG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
IRCCS Policlinico San donato
Milan, 20097
Carlo Pappone, Dr., 0252774260, carlo.pappone@grupposandonato.it
Carlo Pappone, Dr.
About this study
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.
- Conditions
- Brugada Syndrome (BrS), Breast Cancer Females, Colon Cancer, ECG Abnormalities, Autoantibodies Screening
- Being tested
- ECG
- Medical subject headings
- Brugada Syndrome, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECGDiagnostic test
These patients require an ECG to exclude the onset of arrhythmias.
| Study group | Role | What they receive |
|---|---|---|
| breast cancer | Other | Not described Receives: Diagnostic Test: ECG |
| metastatic brest cancer | Other | Not described Receives: Diagnostic Test: ECG |
| colon cancer | Other | Not described Receives: Diagnostic Test: ECG |
| metastatic colon cancer | Other | Not described Receives: Diagnostic Test: ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (at enrollment), 6 months, and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brugada Syndrome (BrS)Studies of the same condition, open and under way.
- More trials run by IRCCS Policlinico S. DonatoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS San Raffaele
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07364656
- Sponsor's protocol ID
- NAV-CARD
- Status last verified
- Oct 2025
- First submitted
- 9 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Presence and Cardiac Functional Effects of Anti-NaV1.5 Autoantibodies in Patients With Metastatic Tumors
- ClinicalTrials.gov ID
- NCT07364656
- Acronym / sponsor ID
- NAV-CARD
- Conditions
- Brugada Syndrome (BrS), Breast Cancer Females, Colon Cancer, ECG Abnormalities, Autoantibodies Screening
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Collaborators
- IRCCS San Raffaele
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| breast cancer | Other | Diagnostic Test: ECG |
| metastatic brest cancer | Other | Diagnostic Test: ECG |
| colon cancer | Other | Diagnostic Test: ECG |
| metastatic colon cancer | Other | Diagnostic Test: ECG |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECGThese patients require an ECG to exclude the onset of arrhythmias. | Diagnostic test | breast cancer, colon cancer, metastatic brest cancer, metastatic colon cancer |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECG in people with Brugada Syndrome (BrS) and Breast Cancer Females, run by IRCCS Policlinico S. Donato at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.