Carcinoid Heart DiseaseCRUSOE-NETsNCT03498040
Development and Progression of Carcinoid Heart Disease in a Cohort of Adult Patients With Neuroendocrine Tumors
An observational study of Carcinoid Heart Disease, run by Hospices Civils de Lyon at 19 sites in France.
Trial summary
Carcinoid Heart Disease (CHD) is a rare form of heart disease, occurring in over 50% of the patients with carcinoid syndrome. Pathophysiology, prognostic factors of development of Carcinoid Heart Disease and progression of disease remain unclear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoid Heart Disease
- What is being tested?
- Study of the occurrence of Carcinoid Heart Disease
- How many people
- 670 participants
- Where
- 19 sitesFrance
- Study dates
- 16 Apr 2018to 16 Apr 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Adult patients with metastatic well-differentiated ileum or bronchial neuroendocrine tumor, adult patients with carcinoid syndrome and/or urinary 5HIAA > 2 fold the upper limit of normal regardless the primary site of the tumor, and therefore likely to develop Carcinoid Heart Disease (CHD).
Who may be able to join
- Patients over 18 years
- Patients followed in a NeuroEndocrine Tumor center with a reference cardiologist
- Patient with:
- Histologically documented metastatic well-differentiated ileum neuroendocrine tumor or
- Histologically documented metastatic well-differentiated bronchial neuroendocrine tumor, or
- Histologically documented well differentiated neuroendocrine tumor, regardless of the primitive site or unknown primitive site and presenting a carcinoid syndrome and / or an elevation of urinary 5HIAA > 2 fold the upper limit of normal range
- Information given to the patient and his documented non-opposition
Who cannot join
- Poorly differentiated neuroendocrine carcinoma
- Patient unable / unwilling to follow the cardiac monitoring recommended by good practice data
- Any medical, geographical, sociological, psychological or legal situation that does not allow the patient to complete the study
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
France19 sites
CHU Amiens
Amiens, 80054
CHU Angers
Angers, 49933
CHU Bordeaux - Hopital Haut-Lévèque
Bordeaux, 33604
APHP Beaujon
Clichy, 92118
CHU Dijon
Dijon
GHICL Lille
Lille, 59000
Centre Oscar Lambret
Lille, 59020
CHRU Lille
Lille, 59037
Hôpital Edouard HERRIOT, Institut du Cancer - Hospices Civils de Lyon
Lyon, 69437
Institut Paoli-Calmettes
Marseille
APHP - Hopital Cochin
Paris, 75014
APHP - Saint Antoine
Paris, 75571
CHU Poitiers
Poitiers, 86021
CHU Reims
Reims
CHU Rennes
Rennes, 35000
Hôpital Haute Pierre
Strasbourg, 67098
CHU Rangueil
Toulouse, 31059
CHRU Tours
Tours, 37044
Institut Gustave Roussy
Villejuif, 94805
About this study
Official title: Development and Progression of Carcinoid Heart Disease in a Cohort of Adult Patients With Neuroendocrine Tumors Carcinoid Heart Disease (CHD): An Observational French Multi-Centre Cohort Study CRUSOE - NETs (CaRdiac UltraSonic OutcomEs - NETs)
Carcinoid Heart Disease (CHD) is a rare form of heart disease, occurring in over 50% of the patients with carcinoid syndrome. Pathophysiology, prognostic factors of development of Carcinoid Heart Disease and progression of disease remain unclear.
This observational multicenter cohort study is designed to study the occurrence of Carcinoid Heart Disease in patients with differentiated carcinoid tumors, to describe numerous factors influencing the occurrence, severity, progression and long-term survival of patients with Carcinoid Heart Disease. Basic informations and detailed diagnosis informations (oncological and cardiac parameters), are collected by professional doctors. Clinical outcomes (onset of Carcinoid Heart Disease, cardiac surgery, related death) will be followed up every year or every six/three months if clinically indicated.
- Conditions
- Carcinoid Heart Disease
- Being tested
- Study of the occurrence of Carcinoid Heart Disease
- Medical subject headings
- Carcinoid Heart Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study of the occurrence of Carcinoid Heart DiseaseOther
Patient at high risk of Carcinoid Heart Disease (metastatic ileum or bronchial well-differentiated neuroendocrine tumors, patients with high level of urinary 5HIAA or with carcinoid syndrome) are followed with annual echocardiography to detect the occurrence of carcinoid heart disease.
In case of documented Carcinoid Heart Disease, a six or three months' cardiac follow-up is necessary to evaluate the progression and the severity of the disease.
Investigators collect the data of clinical parameters (flushes, diarrhea, …) biological parameters (urinary 5HIAA, NT-ProBNP …) and cardiac parameters that may influence the occurrence, severity and progression of Carcinoid Heart Disease.
| Study group | Role | What they receive |
|---|---|---|
| Patients with or at risk of carcinoid heart disease | * Adult patients with well-differentiated metastatic ileum or bronchial neuroendocrine tumor
* Adult patients with carcinoid syndrome or elevated urinary 5HIAA regardless of primary site Receives: Other: Study of the occurrence of Carcinoid Heart Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carcinoid Heart Disease
Percentage of patients with carcinoid heart disease at diagnosis and during follow-up (carcinoid heart disease diagnosis will be assessed by an annual echocardiography).
Measured: 10 years (at the end of study)
Secondary outcomes (3)
Cardiac surgery
Percentage of patients requiring cardiac surgery for the cardiac carcinoid heart disease
Measured: 10 years (at the end of study)
5HIAA levels
Correlation between urinary 5HIAA levels at diagnosis and occurrence of carcinoid heart disease
Measured: 10 years (at the end of study)
Survival
Overall survival in patents with and without carcinoid heart disease
Measured: 10 years (at death or at the end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start16 Apr 2018
- Primary completion16 Apr 2033 (estimated)
- Study completion16 Apr 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoid Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 670 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498040
- Sponsor's protocol ID
- 69HCL17_0700
- Acronym
- CRUSOE-NETs
- Status last verified
- Nov 2024
- First submitted
- 23 Mar 2018
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Progression of Carcinoid Heart Disease in a Cohort of Adult Patients With Neuroendocrine Tumors Carcinoid Heart Disease (CHD): An Observational French Multi-Centre Cohort Study CRUSOE - NETs (CaRdiac UltraSonic OutcomEs - NETs)
- ClinicalTrials.gov ID
- NCT03498040
- Acronym / sponsor ID
- CRUSOE-NETs / 69HCL17_0700
- Conditions
- Carcinoid Heart Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 670 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 16 Apr 2033 (estimated)
- Study completion
- 16 Apr 2033 (estimated)
- First posted
- 13 Apr 2018 (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.
Carcinoid Heart Disease (CHD) is a rare form of heart disease, occurring in over 50% of the patients with carcinoid syndrome. Pathophysiology, prognostic factors of development of Carcinoid Heart Disease and progression of disease remain unclear.
This observational multicenter cohort study is designed to study the occurrence of Carcinoid Heart Disease in patients with differentiated carcinoid tumors, to describe numerous factors influencing the occurrence, severity, progression and long-term survival of patients with Carcinoid Heart Disease. Basic informations and detailed diagnosis informations (oncological and cardiac parameters), are collected by professional doctors. Clinical outcomes (onset of Carcinoid Heart Disease, cardiac surgery, related death) will be followed up every year or every six/three months if clinically indicated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with or at risk of carcinoid heart disease | – | Other: Study of the occurrence of Carcinoid Heart Disease* Adult patients with well-differentiated metastatic ileum or bronchial neuroendocrine tumor * Adult patients with carcinoid syndrome or elevated urinary 5HIAA regardless of primary site |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with metastatic well-differentiated ileum or bronchial neuroendocrine tumor, adult patients with carcinoid syndrome and/or urinary 5HIAA > 2 fold the upper limit of normal regardless the primary site of the tumor, and therefore likely to develop Carcinoid Heart Disease (CHD).
Key inclusion criteria (7 listed)
- Patients over 18 years
- Patients followed in a NeuroEndocrine Tumor center with a reference cardiologist
- Patient with:
- Information given to the patient and his documented non-opposition
Key exclusion criteria (3 listed)
- Poorly differentiated neuroendocrine carcinoma
- Patient unable / unwilling to follow the cardiac monitoring recommended by good practice data
- Any medical, geographical, sociological, psychological or legal situation that does not allow the patient to complete the study
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 |
|---|---|---|
| Study of the occurrence of Carcinoid Heart DiseasePatient at high risk of Carcinoid Heart Disease (metastatic ileum or bronchial well-differentiated neuroendocrine tumors, patients with high level of urinary 5HIAA or with carcinoid syndrome) are followed with annual echocardiography to detect the occurrence of carcinoid heart disease. In case of documented Carcinoid Heart Disease, a six or three months' cardiac follow-up is necessary to evaluate the progression and the severity of the disease. Investigators collect the data of clinical parameters (flushes, diarrhea, …) biological parameters (urinary 5HIAA, NT-ProBNP …) and cardiac parameters that may influence the occurrence, severity and progression of Carcinoid Heart Disease. | Other | Patients with or at risk of carcinoid heart disease |
Primary outcome
Carcinoid Heart Disease
Time frame: 10 years (at the end of study)
Percentage of patients with carcinoid heart disease at diagnosis and during follow-up (carcinoid heart disease diagnosis will be assessed by an annual echocardiography).
3 secondary outcomes
Cardiac surgery
Time frame: 10 years (at the end of study)
5HIAA levels
Time frame: 10 years (at the end of study)
Survival
Time frame: 10 years (at death or at the end of study)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Carcinoid Heart Disease
Active, not recruitingPhase 3
Telotristat Ethyl for the Treatment of Carcinoid Heart Disease in Patients With Metastatic Neuroendocrine Tumor
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Active, not recruiting
Investigation of a Transcatheter Tricuspid Valved Stent Graft in Patients With Carcinoid Heart Disease
Tricuspid Regurgitation, Tricuspid Valve Disease
Not yet recruitingObservational study
CardioNETPOL National Registry of Carcinoid Heart Disease
Carcinoid Heart Disease, Neuroendocrine Tumors
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.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoid Heart Disease, run by Hospices Civils de Lyon at 19 sites in France.
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 7 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carcinoid Heart Disease (time frame: 10 years (at the end of study)). 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 3 Dec 2024.