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NCT Number: NCT03498040

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

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.

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Key information

Conditions

Carcinoid Heart Disease Adenocarcinoma Carcinoid Tumor Carcinoma Cardiovascular Diseases Heart Diseases Malignant Carcinoid Syndrome Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Study of the occurrence of Carcinoid Heart Disease

Other

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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)

Acronym: CRUSOE-NETs

Important dates

Study start
2018
Primary completion
2033
Study completion
2033
First posted
Apr 13, 2018
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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