Early Identification of Cardiac Involvement in Patients With Carcinoid: Clinical and Prognostic Implications

Neuroendocrine Tumors Clinical Trial

Official title:

Early Identification of Cardiac Involvement in Patients With Carcinoid: Clinical and Prognostic Implications

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06321692
• Other study ID #: IEO 1003
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Carcinoid Tumor
• Neuroendocrine Tumors

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 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	6 months