Development and Progression of Carcinoid Heart Disease in a Cohort of Adult Patients With Neuroendocrine Tumors
CRUSOE-NETs
1 other identifier
observational
670
1 country
19
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2018
Longer than P75 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2018
CompletedFirst Posted
Study publicly available on registry
April 13, 2018
CompletedStudy Start
First participant enrolled
April 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 16, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 16, 2033
December 3, 2024
November 1, 2024
15 years
March 23, 2018
November 28, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Cardiac surgery
10 years (at the end of study)
5HIAA levels
10 years (at the end of study)
Survival
10 years (at death or at the end of study)
Study Arms (1)
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
Interventions
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.
Eligibility Criteria
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).
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
CHU Amiens
Amiens, 80054, France
CHU Angers
Angers, 49933, France
CHU Bordeaux - Hopital Haut-Lévèque
Bordeaux, 33604, France
APHP Beaujon
Clichy, 92118, France
CHU Dijon
Dijon, France
GHICL Lille
Lille, 59000, France
Centre Oscar Lambret
Lille, 59020, France
CHRU Lille
Lille, 59037, France
Hôpital Edouard HERRIOT, Institut du Cancer - Hospices Civils de Lyon
Lyon, 69437, France
Institut Paoli-Calmettes
Marseille, France
APHP - Hopital Cochin
Paris, 75014, France
APHP - Saint Antoine
Paris, 75571, France
CHU Poitiers
Poitiers, 86021, France
CHU Reims
Reims, France
CHU Rennes
Rennes, 35000, France
Hôpital Haute Pierre
Strasbourg, 67098, France
CHU Rangueil
Toulouse, 31059, France
CHRU Tours
Tours, 37044, France
Institut Gustave Roussy
Villejuif, 94805, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2018
First Posted
April 13, 2018
Study Start
April 16, 2018
Primary Completion (Estimated)
April 16, 2033
Study Completion (Estimated)
April 16, 2033
Last Updated
December 3, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share