Clinical trial NCT03863106: The Lyon Real World Evidence in Metastatic NeuroEndocrine Tumours
Official title: The Lyon Real World Evidence in Metastatic NeuroEndocrine Tumours
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastro-enteropancreatic Neuroendocrine Tumor
Health Care Costs
Metastatic Cancer
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 880
Sex: ALL
Minimum age (years): 15
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with i) a diagnosis of metastatic NET, either synchronous or metachronous, ii) between 1 January 1990 and 31 December of 2017, and iii) seen in the Hospices Civils de Lyon.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Cost in euros per year of healthcare resources related to the management of metastatic NETs patients.
timeFrame: 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 outcomes:
measure: Treatments patterns in metastatic NETs patients
timeFrame: From diagnosis until first occurrence of each treatment, through study completion, estimated on september 2018
measure: Treatments patterns in metastatic NETs patients
timeFrame: From diagnosis until first occurrence of each treatment, through study completion, estimated on september 2018
measure: Overall survival
timeFrame: From the date of metastatic diagnosis of NETs to the date of death or last-follow-up, through study completion, estimated on september 2018
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
References:
citation: Lemelin A, Maucort-Boulch D, Castel-Kremer E, Forestier J, Hervieu V, Lorcet M, Boutitie F, Theillaumas A, Robinson P, Duclos A, Lombard-Bohas C, Walter T. Elderly Patients with Metastatic Neuroendocrine Tumors Are Undertreated and Have Shorter Survival: The LyREMeNET Study. Neuroendocrinology. 2020;110(7-8):653-661. doi: 10.1159/000503901. Epub 2019 Oct 7.