Clinical trial NCT03498040: Development and Progression of Carcinoid Heart Disease in a Cohort of Adult Patients With Neuroendocrine Tumors
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)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Carcinoid Heart Disease
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-04-13
Enrollment: 670
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


Eligibility 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

Primary outcomes:
measure: Carcinoid Heart Disease
timeFrame: 10 years (at the end of study)
Secondary outcomes:
measure: Cardiac surgery
timeFrame: 10 years (at the end of study)
measure: 5HIAA levels
timeFrame: 10 years (at the end of study)
measure: Survival
timeFrame: 10 years (at death or at the end of study)
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Angers
country: France
facility: CHU Angers
city: Bordeaux
country: France
facility: CHU Bordeaux - Hopital Haut-Lévèque
city: Clichy
country: France
facility: APHP Beaujon
city: Dijon
country: France
facility: CHU Dijon
city: Lille
country: France
facility: GHICL Lille
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lille
country: France
facility: CHRU Lille
city: Lyon
country: France
facility: Hôpital Edouard HERRIOT, Institut du Cancer - Hospices Civils de Lyon
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Paris
country: France
facility: APHP - Hopital Cochin
city: Paris
country: France
facility: APHP - Saint Antoine
city: Poitiers
country: France
facility: CHU Poitiers
city: Reims
country: France
facility: CHU Reims
city: Rennes
country: France
facility: CHU Rennes
city: Strasbourg
country: France
facility: Hôpital Haute Pierre
city: Toulouse
country: France
facility: CHU Rangueil
city: Tours
country: France
facility: CHRU Tours
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
References: