Early Identification of Cardiac Involvement in Patients With Carcinoid: Clinical and Prognostic Implications
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 9, 2019
CompletedFirst Submitted
Initial submission to the registry
March 13, 2024
CompletedFirst Posted
Study publicly available on registry
March 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedMarch 20, 2024
March 1, 2024
5.2 years
March 13, 2024
March 13, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
Correlation between the levels of the biomarkers and the presence/entity of cardiac involvement
6 months
Study Arms (1)
Evaluation of blood levels of biomarkers of cardiac damage
OTHEREvaluation 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
Interventions
Evaluation of ultra-sensitive troponin I, BNP, NT-proBNP, and ST2 in patients with diagnosed neuroendocrine tumours (NET) with or without carcinoid syndrome
Eligibility Criteria
You may qualify if:
- patients diagnosed with metastatic NET with or without carcinoid referred to the Unit of Neuroendocrine Tumors of European Institute of Oncology
You may not qualify if:
- age \<18 years
- patients diagnosed with heart disease prior to diagnosis of NET
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
European Institute of Oncology
Milan, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniela Cardinale, MD
European Institute of Oncology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2024
First Posted
March 20, 2024
Study Start
October 9, 2019
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
March 20, 2024
Record last verified: 2024-03