The Lyon Real World Evidence in Metastatic NeuroEndocrine Tumours

NCT03863106 | Unknown

• 1 other identifier: LyREMeNet
• Study Type: observational
• Target: 880
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastro-enteropancreatic Neuroendocrine Tumor; Health Care Costs; Metastatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Treatments patterns in metastatic NETs patients

  From diagnosis until first occurrence of each treatment, 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

• 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

Interventions

Metastatic gastroenteropancreatic and lung neuroendocrine tumors OTHER

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.

Also known as: Metastatic NETs population description Healthcare resources use and related cost Clinical parameter: Demographic and tumour characteristics, treatments patterns

Eligibility Criteria

• Age: 15 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Poorly differentiated neuroendocrine carcinoma
• Histologic mixed neuroendocrine tumour

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69003, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 31586998 DERIVED

MeSH Terms

Conditions

Gastro-enteropancreatic neuroendocrine tumor; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

THOMAS WALTER, Dr

CONTACT

+33 (0) 4 72 11 73 98; thomas.walter@chu-lyon.fr

EMILIE PROME

CONTACT

+33 (0) 4 72 11 62 03; emilie.prome@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: March 5, 2019
• Study Start: July 15, 2017
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2020
• Last Updated: March 5, 2019

Record last verified: 2019-03

Locations

FR (1)