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

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.

Study Overview

• Status: Recruiting
• Conditions: Neuroendocrine Tumors
• Intervention / Treatment: Other: Evaluation of blood levels of biomarkers of cardiac damage

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

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniela Cardinale, MD; Phone Number: +39 0257489748; Email: daniela.cardinale@ieo.it

Study Locations

• Italy
  • Milan, Italy
    • Recruiting
    • European Institute of Oncology
    • Contact: Daniela Cardinale, MD; Email: daniela.cardinale@ieo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Evaluation of blood levels of biomarkers of cardiac damage; 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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; 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

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Principal Investigator: Daniela Cardinale, MD, European Institute of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2019
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Carcinoid Tumor
• Other Study ID Numbers: IEO 1003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No