Development and Progression of Carcinoid Heart Disease in a Cohort of Adult Patients With Neuroendocrine Tumors (CRUSOE-NETs)

Civil Hospices of Lyon

Status: Active, not recruiting

Conditions: Carcinoid Heart Disease

Treatments: Other: Study of the occurrence of Carcinoid Heart Disease

Study type: Observational

Funder types: Other

Identifiers

NCT03498040

69HCL17_0700

Details and patient eligibility

About

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.

Enrollment: 670 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

670 participants in 1 patient group

Patients with or at risk of carcinoid heart disease

Description:

* Adult patients with well-differentiated metastatic ileum or bronchial neuroendocrine tumor * Adult patients with carcinoid syndrome or elevated urinary 5HIAA regardless of primary site

Treatment:

Other: Study of the occurrence of Carcinoid Heart Disease