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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06321692
Other study ID # IEO 1003
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 9, 2019
Est. completion date December 31, 2024

Study information

Verified date March 2024
Source European Institute of Oncology
Contact Daniela Cardinale, MD
Phone +39 0257489748
Email daniela.cardinale@ieo.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Evaluation 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

Locations

Country Name City State
Italy European Institute of Oncology Milan

Sponsors (1)

Lead Sponsor Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary blood levels of biomarkers of cardiac damage Evaluation of blood levels of ultra-sensitive troponin I 3 months
Primary blood levels of biomarkers of hemodynamic impairment Evaluation of blood levels of BNP, NT-proBNP 3 months
Primary blood levels of biomarkers of cardiac fibrosis Evaluation of blood levels of ST2 3 months
Secondary 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 beĆ¹
Tricuspid valve regurgitation, ranging from mild to severe
Pulmonary valve regurgitation and/or stenosis
Dilated right atrium
Dilated right ventricle
Reduced right ventricular function
6 months
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