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

Overview

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.

Full Title of Study: “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)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 2033

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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).

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospices Civils de Lyon
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Catherine LOMBARD-BOHAS, Dr, 04 72 11 91 67, catherine.lombard@chu-lyon.fr

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