The Lyon Real World Evidence in Metastatic NeuroEndocrine Tumours

Study Overview
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Brief Summary
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Neuroendocrine tumours (NETs) are rare and include a heterogeneous group of neoplasms derived from the endocrine system found in the gastrointestinal tract, pancreas and lung. Gastroenteropancreatic (GEP) NETs represent the majority of neuroendocrine neoplasms (NEN) and the annual incidence of all GEP-NETs has been estimated to 6.98 per 100,000 person-years in 2012 and is steadily rising. While data on the incidence of metastatic GEP-NET is limited, more than 50% of patients with GEP-NET have metastatic disease at the time of diagnosis. Incorrect and delayed diagnoses are still common. Treatment options include surgery, locoregional interventions, and systemic treatment. The Lyon Real world Evidence in Metastatic NeuroEndocrine Tumours study (LyREMeNET) is a descriptive observational cohort study. The main objective is to assess the healthcare resources use and the corresponding costs for management of patients with metastatic GEP and lung NETs. The secondary objective is to describe the clinical characteristics, prognostic factors, treatment patterns, and the overall survival among patients with metastatic GEP and lung NETs.

Official Title
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The Lyon Real World Evidence in Metastatic NeuroEndocrine Tumours

Conditions
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Gastro-enteropancreatic Neuroendocrine Tumor, Health Care Costs, Metastatic Cancer

Intervention / Treatment
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* Other: Metastatic gastroenteropancreatic and lung neuroendocrine tumors


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a diagnosis of well-differentiated metastatic neuroendocrine tumour (either synchronous or metachronous) Diagnosis performed between 1 January 1990 and 31 December of 2017 Patients seen at least once at the oncologic department of Hospices Civils de Lyon. Exclusion Criteria: Poorly differentiated neuroendocrine carcinoma Histologic mixed neuroendocrine tumour

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Metastatic gastroenteropancreatic and lung neuroendocrine tumors|Patients with metastatic GEP and lung NETs will be selected via the Cancer Database on NEN of the Hospices Civils de Lyon. Data from this database will be matched with the French nationwide claims and hospitalization database (SNDS database), allowing access to the corresponding healthcare resources use and their related costs. Data regarding clinical and tumour characteristics and treatments patterns will be collected via the database between 1 January 1990 and 31 of December 2017.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost in euros per year of healthcare resources related to the management of metastatic NETs patients. |  | The cost will be calculated, per year, from the date of metastatic diagnosis of NETs to the date of death or last follow-up (study end in September 2018) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatments patterns in metastatic NETs patients | Number of interventional and systemic treatments | From diagnosis until first occurrence of each treatment, through study completion, estimated on september 2018 | 
| Treatments patterns in metastatic NETs patients | Cumulative duration in months of systemic treatments | From diagnosis until first occurrence of each treatment, through study completion, estimated on september 2018 | 
| Overall survival |  | From the date of metastatic diagnosis of NETs to the date of death or last-follow-up, through study completion, estimated on september 2018 |