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

NCT ID: NCT06321692

Condition: Neuroendocrine Tumors

Conditions: Official terms:
Neuroendocrine Tumors
Carcinoid Tumor

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Evaluation of blood levels of biomarkers of cardiac damage
Description: Evaluation of ultra-sensitive troponin I, BNP, NT-proBNP, and ST2 in patients with diagnosed neuroendocrine tumours (NET) with or without carcinoid syndrome
Arm group label: Evaluation of blood levels of biomarkers of cardiac damage

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

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: European Institute of Oncology

Address:
City: Milan
Country: Italy

Status: Recruiting

Contact:
Last name: Daniela Cardinale, MD
Email: daniela.cardinale@ieo.it

Start date: October 9, 2019

Completion date: December 31, 2024

Lead sponsor:
Agency: European Institute of Oncology
Agency class: Other

Source: European Institute of Oncology

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06321692

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