The Lyon Real World Evidence in Metastatic NeuroEndocrine Tumours

Metastatic Cancer Clinical Trial

— LyREMeNet  

Official title:

The Lyon Real World Evidence in Metastatic NeuroEndocrine Tumours

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03863106
• Other study ID #: LyREMeNet
• Status: Recruiting
• Start date: July 15, 2017
• Est. completion date: July 2020

Study information

• Verified date: March 2019
• Source: Hospices Civils de Lyon
• Contact: THOMAS WALTER, Dr
• Phone: +33 (0) 4 72 11 73 98
• Email: thomas.walter[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 880
• Est. completion date: July 2020
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastro-enteropancreatic Neuroendocrine Tumor
• Health Care Costs
• Intestinal Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis
• Neuroendocrine Tumors
• Pancreatic Neoplasms
• Stomach Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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