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

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ClinicalTrials.gov Identifier: NCT03498040
Recruitment Status : Not yet recruiting
First Posted : April 13, 2018
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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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.


Condition or disease Intervention/treatment
Carcinoid Heart Disease Other: Study of the occurrence of Carcinoid Heart Disease

Study Design
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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : April 2033
Estimated Study Completion Date : April 2033

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Cardiac surgery [ Time Frame: 10 years (at the end of study) ]
    Percentage of patients requiring cardiac surgery for the cardiac carcinoid heart disease

  2. 5HIAA levels [ Time Frame: 10 years (at the end of study) ]
    Correlation between urinary 5HIAA levels at diagnosis and occurrence of carcinoid heart disease

  3. Survival [ Time Frame: 10 years (at death or at the end of study) ]
    Overall survival in patents with and without carcinoid heart disease


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498040


Contacts
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Contact: Catherine LOMBARD-BOHAS, Dr 04 72 11 91 67 ext +33 catherine.lombard@chu-lyon.fr
Contact: Laurent FRANCOIS, Dr 04 72 35 71 62 ext +33 laurent.francois@chu-lyon.fr

Locations
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France
Hôpital Edouard HERRIOT, Institut du Cancer - Hospices Civils de Lyon
Lyon, France, 69437
Contact: Catherine LOMBARD-BOHAS, Dr    04 72 11 91 67 ext +33    catherine.lombard@chu-lyon.fr   
Contact: Laurent FRANCOIS, Dr    04 72 35 71 62 ext +33    laurent.francois@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03498040    
Other Study ID Numbers: 69HCL17_0700
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Carcinoid Tumor
Carcinoid Heart Disease
Heart Diseases
Cardiovascular Diseases
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Malignant Carcinoid Syndrome