Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2025-12-27 @ 8:02 PM
Study NCT ID:
NCT06321692
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Identification of Cardiac Involvement in Patients With Carcinoid: Clinical and Prognostic Implications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}], 'ancestors': [{'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-13', 'studyFirstSubmitDate': '2024-03-13', 'studyFirstSubmitQcDate': '2024-03-13', 'lastUpdatePostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blood levels of biomarkers of cardiac damage', 'timeFrame': '3 months', 'description': 'Evaluation of blood levels of ultra-sensitive troponin I'}, {'measure': 'blood levels of biomarkers of hemodynamic impairment', 'timeFrame': '3 months', 'description': 'Evaluation of blood levels of BNP, NT-proBNP'}, {'measure': 'blood levels of biomarkers of cardiac fibrosis', 'timeFrame': '3 months', 'description': 'Evaluation of blood levels of ST2'}], 'secondaryOutcomes': [{'measure': 'Correlation between the levels of the biomarkers and the presence/entity of cardiac involvement', 'timeFrame': '6 months', 'description': 'Correlation between the levels of the biomarkers and echocardiographic features to define cardiac involvement.\n\nThe features considered to define the cardiac involvement will beù\n\n* Tricuspid valve regurgitation, ranging from mild to severe\n* Pulmonary valve regurgitation and/or stenosis\n* Dilated right atrium\n* Dilated right ventricle\n* Reduced right ventricular function'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neuroendocrine Tumors']}, 'descriptionModule': {'briefSummary': 'This study is for patients with neuroendocrine tumours (NET) with or without carcinoid syndrome followed by NET Unit of European Institute of Oncology.\n\nThe objective of the trial is to evaluate biochemical markers of myocardial injury (high-sensitive troponins), haemodyinamic markers (pro-brain natriuretic peptide (BNP), N-terminal (NT)-BNP (NT-proBNP)), and markers of fibrosis (Suppression of Tumorigenicity 2 (ST2) in patients with neuroendocrine tumours (NET) with or without carcinoid syndrome.', 'detailedDescription': 'The main aim of this study is to evaluate blood levels of biomarkers of cardiac damage (ultra-sensitive troponin I), hemodynamic impairment (BNP, NT-proBNP), and cardiac fibrosis (ST2) in patients with diagnosed neuroendocrine tumours (NET) with or without carcinoid syndrome The secondary objective is to correlate the levels of the above markers with the presence/entity of cardiac involvement and its progression over time.\n\nAll patients will undergo:\n\n* a baseline assessment including:\n\n * blood sampling for US-Troponin I, BNP, NT-proBNP, ST2\n * cardiological evaluation including ECG and echocardiogram\n* a three-monthly revaluation of these markers\n* a six monthly cardiological reassessment with a echocardiogram'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients diagnosed with metastatic NET with or without carcinoid referred to the Unit of Neuroendocrine Tumors of European Institute of Oncology\n\nExclusion Criteria:\n\n* age \\<18 years\n* patients diagnosed with heart disease prior to diagnosis of NET'}, 'identificationModule': {'nctId': 'NCT06321692', 'briefTitle': 'Early Identification of Cardiac Involvement in Patients With Carcinoid: Clinical and Prognostic Implications', 'organization': {'class': 'OTHER', 'fullName': 'European Institute of Oncology'}, 'officialTitle': 'Early Identification of Cardiac Involvement in Patients With Carcinoid: Clinical and Prognostic Implications', 'orgStudyIdInfo': {'id': 'IEO 1003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Evaluation of blood levels of biomarkers of cardiac damage', 'description': 'Evaluation of blood levels of biomarkers of cardiac damage (ultra-sensitive troponin I), hemodynamic impairment (BNP, NT-proBNP), and cardiac fibrosis (ST2) in patients with diagnosed neuroendocrine tumours (NET) with or without carcinoid syndrome', 'interventionNames': ['Other: Evaluation of blood levels of biomarkers of cardiac damage']}], 'interventions': [{'name': 'Evaluation of blood levels of biomarkers of cardiac damage', 'type': 'OTHER', 'description': 'Evaluation of ultra-sensitive troponin I, BNP, NT-proBNP, and ST2 in patients with diagnosed neuroendocrine tumours (NET) with or without carcinoid syndrome', 'armGroupLabels': ['Evaluation of blood levels of biomarkers of cardiac damage']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Daniela Cardinale, MD', 'role': 'CONTACT', 'email': 'daniela.cardinale@ieo.it'}], 'facility': 'European Institute of Oncology', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Daniela Cardinale, MD', 'role': 'CONTACT', 'email': 'daniela.cardinale@ieo.it', 'phone': '+39 0257489748'}], 'overallOfficials': [{'name': 'Daniela Cardinale, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'European Institute of Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Institute of Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}