Development and Progression of Carcinoid Heart Disease in a Cohort of Adult Patients With Neuroendocrine Tumors

Carcinoid Heart Disease Clinical Trial

— CRUSOE-NETs  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03498040
• Other study ID #: 69HCL17_0700
• Status: Not yet recruiting
• First received: March 23, 2018
• Last updated: April 6, 2018
• Start date: April 2018
• Est. completion date: April 2033

Study information

• Verified date: March 2018
• Source: Hospices Civils de Lyon
• Contact: Catherine LOMBARD-BOHAS, Dr
• Phone: 04 72 11 91 67
• Email: catherine.lombard[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: April 2033
• Est. primary completion date: April 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Carcinoid Heart Disease
• Carcinoid Tumor
• Heart Diseases
• Neuroendocrine Tumors

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Edouard HERRIOT, Institut du Cancer - Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	10 years (at the end of study)
Secondary	Cardiac surgery	Percentage of patients requiring cardiac surgery for the cardiac carcinoid heart disease	10 years (at the end of study)
Secondary	5HIAA levels	Correlation between urinary 5HIAA levels at diagnosis and occurrence of carcinoid heart disease	10 years (at the end of study)
Secondary	Survival	Overall survival in patents with and without carcinoid heart disease	10 years (at death or at the end of study)