Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2025-12-27 @ 8:02 PM
Study NCT ID:
NCT06321692
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Identification of Cardiac Involvement in Patients With Carcinoid: Clinical and Prognostic Implications
Sponsor:
European Institute of Oncology
Organization:
Study Overview
Official Title:
Early Identification of Cardiac Involvement in Patients With Carcinoid: Clinical and Prognostic Implications
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: