Development and Progression of Carcinoid Heart Disease in a Cohort of Adult Patients With Neuroendocrine Tumors (CRUSOE-NETs)
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|ClinicalTrials.gov Identifier: NCT03498040|
Recruitment Status : Not yet recruiting
First Posted : April 13, 2018
Last Update Posted : April 13, 2018
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.
|Condition or disease||Intervention/treatment|
|Carcinoid Heart Disease||Other: Study of the occurrence of Carcinoid Heart Disease|
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|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)|
|Estimated Study Start Date :||April 2018|
|Estimated Primary Completion Date :||April 2033|
|Estimated Study Completion Date :||April 2033|
Patients with or at risk of carcinoid heart disease
Other: 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.
- 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).
- Cardiac surgery [ Time Frame: 10 years (at the end of study) ]Percentage of patients requiring cardiac surgery for the cardiac carcinoid heart disease
- 5HIAA levels [ Time Frame: 10 years (at the end of study) ]Correlation between urinary 5HIAA levels at diagnosis and occurrence of carcinoid heart disease
- Survival [ Time Frame: 10 years (at death or at the end of study) ]Overall survival in patents with and without carcinoid heart disease
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498040
|Contact: Catherine LOMBARD-BOHAS, Dr||04 72 11 91 67 ext +email@example.com|
|Contact: Laurent FRANCOIS, Dr||04 72 35 71 62 ext +firstname.lastname@example.org|
|Hôpital Edouard HERRIOT, Institut du Cancer - Hospices Civils de Lyon|
|Lyon, France, 69437|
|Contact: Catherine LOMBARD-BOHAS, Dr 04 72 11 91 67 ext +33 email@example.com|
|Contact: Laurent FRANCOIS, Dr 04 72 35 71 62 ext +33 firstname.lastname@example.org|