Neuroendocrine TumorsNCT06321692
Early Identification of Cardiac Involvement in Patients With Carcinoid: Clinical and Prognostic Implications
A study testing Evaluation of blood levels of biomarkers of cardiac damage in people with Neuroendocrine Tumors, run by European Institute of Oncology at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- Evaluation of blood levels of biomarkers of cardiac damage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 9 Oct 2019to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients diagnosed with metastatic NET with or without carcinoid referred to the Unit of Neuroendocrine Tumors of European Institute of Oncology
Who cannot join
- age <18 years
- patients diagnosed with heart disease prior to diagnosis of NET
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncology
Milan
Daniela Cardinale, MD, daniela.cardinale@ieo.it
About this study
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.
Read the 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
- Conditions
- Neuroendocrine Tumors
- Being tested
- Evaluation of blood levels of biomarkers of cardiac damage
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of blood levels of biomarkers of cardiac damageOther
Evaluation of ultra-sensitive troponin I, BNP, NT-proBNP, and ST2 in patients with diagnosed neuroendocrine tumours (NET) with or without carcinoid syndrome
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of blood levels of biomarkers of cardiac damage | Other | 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 Receives: Other: Evaluation of blood levels of biomarkers of cardiac damage |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood levels of biomarkers of cardiac damage
Evaluation of blood levels of ultra-sensitive troponin I
Measured: 3 months
blood levels of biomarkers of hemodynamic impairment
Evaluation of blood levels of BNP, NT-proBNP
Measured: 3 months
blood levels of biomarkers of cardiac fibrosis
Evaluation of blood levels of ST2
Measured: 3 months
Secondary outcomes (1)
Correlation between the levels of the biomarkers and the presence/entity of cardiac involvement
Correlation between the levels of the biomarkers and echocardiographic features to define cardiac involvement.
The features considered to define the cardiac involvement will beù
- Tricuspid valve regurgitation, ranging from mild to severe
- Pulmonary valve regurgitation and/or stenosis
- Dilated right atrium
- Dilated right ventricle
- Reduced right ventricular function
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start9 Oct 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniela Cardinale, MD, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321692
- Sponsor's protocol ID
- IEO 1003
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Identification of Cardiac Involvement in Patients With Carcinoid: Clinical and Prognostic Implications
- ClinicalTrials.gov ID
- NCT06321692
- Acronym / sponsor ID
- IEO 1003
- Conditions
- Neuroendocrine Tumors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 9 Oct 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of blood levels of biomarkers of cardiac damage | Other | Other: Evaluation of blood levels of biomarkers of cardiac damageEvaluation 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients diagnosed with metastatic NET with or without carcinoid referred to the Unit of Neuroendocrine Tumors of European Institute of Oncology
Key exclusion criteria (2 listed)
- age <18 years
- patients diagnosed with heart disease prior to diagnosis of NET
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of blood levels of biomarkers of cardiac damageEvaluation of ultra-sensitive troponin I, BNP, NT-proBNP, and ST2 in patients with diagnosed neuroendocrine tumours (NET) with or without carcinoid syndrome | Other | Evaluation of blood levels of biomarkers of cardiac damage |
Primary outcome
blood levels of biomarkers of cardiac damage
Time frame: 3 months
Evaluation of blood levels of ultra-sensitive troponin I
blood levels of biomarkers of hemodynamic impairment
Time frame: 3 months
Evaluation of blood levels of BNP, NT-proBNP
blood levels of biomarkers of cardiac fibrosis
Time frame: 3 months
Evaluation of blood levels of ST2
1 secondary outcome
Correlation between the levels of the biomarkers and the presence/entity of cardiac involvement
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniela Cardinale, MD principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of blood levels of biomarkers of cardiac damage in people with Neuroendocrine Tumors, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniela Cardinale, MD (+39 0257489748, daniela.cardinale@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood levels of biomarkers of cardiac damage (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.