Development and Progression of Carcinoid Heart Disease in a Cohort of Adult Patients With Neuroendocrine Tumors
NCT ID: NCT03498040
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
670 participants
OBSERVATIONAL
2018-04-16
2033-04-16
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
Study of the occurrence of Carcinoid Heart Disease
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.
Interventions
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Study of the occurrence of Carcinoid Heart Disease
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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CHU Amiens
Amiens, , France
CHU Angers
Angers, , France
CHU Bordeaux - Hopital Haut-Lévèque
Bordeaux, , France
APHP Beaujon
Clichy, , France
CHU Dijon
Dijon, , France
GHICL Lille
Lille, , France
Centre Oscar Lambret
Lille, , France
CHRU Lille
Lille, , France
Hôpital Edouard HERRIOT, Institut du Cancer - Hospices Civils de Lyon
Lyon, , France
Institut Paoli-Calmettes
Marseille, , France
APHP - Hopital Cochin
Paris, , France
APHP - Saint Antoine
Paris, , France
CHU Poitiers
Poitiers, , France
CHU Reims
Reims, , France
CHU Rennes
Rennes, , France
Hôpital Haute Pierre
Strasbourg, , France
CHU Rangueil
Toulouse, , France
CHRU Tours
Tours, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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Other Identifiers
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69HCL17_0700
Identifier Type: -
Identifier Source: org_study_id