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

European Institute of Oncology

Status: Enrolling

Conditions: Neuroendocrine Tumors

Treatments: Other: Evaluation of blood levels of biomarkers of cardiac damage

Study type: Interventional

Funder types: Other

Identifiers

NCT06321692

IEO 1003

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

100 participants in 1 patient group

Evaluation of blood levels of biomarkers of cardiac damage

Other group

Description:

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

Treatment:

Other: Evaluation of blood levels of biomarkers of cardiac damage