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

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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Carcinoid Heart Disease
• Intervention / Treatment: Other: Study of the occurrence of Carcinoid Heart Disease

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Catherine LOMBARD-BOHAS, Dr; Phone Number: +33 04 72 11 91 67; Email: catherine.lombard@chu-lyon.fr
• Study Contact Backup: Name: Laurent FRANCOIS, Dr; Phone Number: +33 04 72 35 71 62; Email: laurent.francois@chu-lyon.fr

Study Locations

• France
  • Lyon, France, 69437
    • Hôpital Edouard HERRIOT, Institut du Cancer - Hospices Civils de Lyon
    • Contact: Catherine LOMBARD-BOHAS, Dr; Phone Number: +33 04 72 11 91 67; Email: catherine.lombard@chu-lyon.fr
    • Contact: Laurent FRANCOIS, Dr; Phone Number: +33 04 72 35 71 62; Email: laurent.francois@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with metastatic well-differentiated ileum or bronchial neuroendocrine tumor, adult patients with carcinoid syndrome and/or urinary 5HIAA > 2 fold the upper limit of normal regardless the primary site of the tumor, and therefore likely to develop Carcinoid Heart Disease (CHD).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2018
• Primary Completion (Anticipated): April 1, 2033
• Study Completion (Anticipated): April 1, 2033

Study Registration Dates

• First Submitted: March 23, 2018
• First Submitted That Met QC Criteria: April 6, 2018
• First Posted (Actual): April 13, 2018

Study Record Updates

• Last Update Posted (Actual): April 13, 2018
• Last Update Submitted That Met QC Criteria: April 6, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Malignant Carcinoid Syndrome; Heart Diseases; Neuroendocrine Tumors; Carcinoid Tumor; Carcinoid Heart Disease
• Other Study ID Numbers: 69HCL17_0700

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No