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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