The Lyon Real World Evidence in Metastatic NeuroEndocrine Tumours

• Conditions: Gastro-enteropancreatic Neuroendocrine Tumor; Health Care Costs; Metastatic Cancer

• Registration Number: NCT03863106
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-15
• Study First Submitted: 2018-09-27
• Status Verified: 2019-03
• Study First Submitted QC: 2019-03-04
• Last Update Submitted: 2019-03-04
• Study First Posted: 2019-03-05
• Last Update Posted: 2019-03-05
• Primary Completion: 2019-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 880

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.

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Exclusion Criteria

• Poorly differentiated neuroendocrine carcinoma
• Histologic mixed neuroendocrine tumour

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Treatments patterns in metastatic NETs patients	From diagnosis until first occurrence of each treatment, through study completion, estimated on september 2018	Cumulative duration in months of systemic treatments

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Lyon, France