Neuroendocrine Tumors
Conditions
Brief summary
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.
Detailed description
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: * blood sampling for US-Troponin I, BNP, NT-proBNP, ST2 * cardiological evaluation including ECG and echocardiogram * a three-monthly revaluation of these markers * a six monthly cardiological reassessment with a echocardiogram
Interventions
OTHEREvaluation of blood levels of biomarkers of cardiac damage
Evaluation of ultra-sensitive troponin I, BNP, NT-proBNP, and ST2 in patients with diagnosed neuroendocrine tumours (NET) with or without carcinoid syndrome
Sponsors
European Institute of Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients diagnosed with metastatic NET with or without carcinoid referred to the Unit of Neuroendocrine Tumors of European Institute of Oncology
Exclusion criteria
* age \<18 years * patients diagnosed with heart disease prior to diagnosis of NET
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| blood levels of biomarkers of cardiac damage | 3 months | Evaluation of blood levels of ultra-sensitive troponin I |
| blood levels of biomarkers of hemodynamic impairment | 3 months | Evaluation of blood levels of BNP, NT-proBNP |
| blood levels of biomarkers of cardiac fibrosis | 3 months | Evaluation of blood levels of ST2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between the levels of the biomarkers and the presence/entity of cardiac involvement | 6 months | Correlation between the levels of the biomarkers and echocardiographic features to define cardiac involvement. The features considered to define the cardiac involvement will beù * Tricuspid valve regurgitation, ranging from mild to severe * Pulmonary valve regurgitation and/or stenosis * Dilated right atrium * Dilated right ventricle * Reduced right ventricular function |
Countries
Italy
Contacts
Primary ContactDaniela Cardinale, MD
Outcome results
None listed