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This study is for patients with neuroendocrine tumours (NET) with or without carcinoid syndrome followed by NET Unit of European Institute of Oncology.
The 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.
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.
All patients will undergo:
a baseline assessment including:
a three-monthly revaluation of these markers
a six monthly cardiological reassessment with a echocardiogram
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evaluation of blood levels of biomarkers of cardiac damage | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluation of blood levels of biomarkers of cardiac damage | Other | Evaluation of ultra-sensitive troponin I, BNP, NT-proBNP, and ST2 in patients with diagnosed neuroendocrine tumours (NET) with or without carcinoid syndrome |
| Measure | Description | Time Frame |
|---|---|---|
| blood levels of biomarkers of cardiac damage | Evaluation of blood levels of ultra-sensitive troponin I | 3 months |
| blood levels of biomarkers of hemodynamic impairment | Evaluation of blood levels of BNP, NT-proBNP | 3 months |
| blood levels of biomarkers of cardiac fibrosis | Evaluation of blood levels of ST2 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between the levels of the biomarkers and the presence/entity of cardiac involvement | Correlation between the levels of the biomarkers and echocardiographic features to define cardiac involvement. The features considered to define the cardiac involvement will beù
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniela Cardinale, MD | Contact | +39 0257489748 | daniela.cardinale@ieo.it |
| Name | Affiliation | Role |
|---|---|---|
| Daniela Cardinale, MD | European Institute of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Institute of Oncology | Recruiting | Milan | Italy |
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| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 6 months |
| D009380 | Neoplasms, Nerve Tissue |