Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 8:39 AM
Study NCT ID:
NCT07364656
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-23
First Post:
2026-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of the Presence and Cardiac Functional Effects of Anti-NaV1.5 Autoantibodies in Patients With Metastatic Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053840', 'term': 'Brugada Syndrome'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004562', 'term': 'Electrocardiography'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 196}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-16', 'studyFirstSubmitDate': '2026-01-09', 'studyFirstSubmitQcDate': '2026-01-16', 'lastUpdatePostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'timeFrame': 'Baseline (at enrollment), 6 months, and 12 months.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brugada Syndrome (BrS)', 'Breast Cancer Females', 'Colon Cancer', 'ECG Abnormalities', 'Autoantibodies Screening']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patients with a confirmed diagnosis of breast or colorectal cancer, either metastatic or non-metastatic\n* Patients already receiving first-line therapy with a confirmed diagnosis of breast or colorectal cancer, either metastatic or non-metastatic\n* Signed informed consent\n\nExclusion Criteria:\n\n* Clinically significant cardiovascular diseases (atrial fibrillation, congestive heart failure, cardiomyopathies, or inherited arrhythmic syndromes)\n* Known autoimmune diseases or immunodeficiencies\n* Use of high-dose immunosuppressive drugs or other experimental treatments that could interfere with the assessment of study endpoints'}, 'identificationModule': {'nctId': 'NCT07364656', 'briefTitle': 'Analysis of the Presence and Cardiac Functional Effects of Anti-NaV1.5 Autoantibodies in Patients With Metastatic Tumors', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Policlinico S. Donato'}, 'officialTitle': 'Analysis of the Presence and Cardiac Functional Effects of Anti-NaV1.5 Autoantibodies in Patients With Metastatic Tumors', 'orgStudyIdInfo': {'id': 'NAV-CARD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'breast cancer', 'interventionNames': ['Diagnostic Test: ECG']}, {'type': 'OTHER', 'label': 'metastatic brest cancer', 'interventionNames': ['Diagnostic Test: ECG']}, {'type': 'OTHER', 'label': 'colon cancer', 'interventionNames': ['Diagnostic Test: ECG']}, {'type': 'OTHER', 'label': 'metastatic colon cancer', 'interventionNames': ['Diagnostic Test: ECG']}], 'interventions': [{'name': 'ECG', 'type': 'DIAGNOSTIC_TEST', 'description': 'These patients require an ECG to exclude the onset of arrhythmias.', 'armGroupLabels': ['breast cancer', 'colon cancer', 'metastatic brest cancer', 'metastatic colon cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20097', 'city': 'Milan', 'country': 'Italy', 'contacts': [{'name': 'Carlo Pappone, Dr.', 'role': 'CONTACT', 'email': 'carlo.pappone@grupposandonato.it', 'phone': '0252774260'}, {'name': 'Carlo Pappone, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Policlinico San donato', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Policlinico S. Donato', 'class': 'OTHER'}, 'collaborators': [{'name': 'IRCCS San Raffaele', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}