LyREMeNet: The Lyon Real World Evidence in Metastatic NeuroEndocrine Tumours

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Unknown status
CT.gov ID
NCT03863106
Collaborator
(none)
880
1
35.5
24.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Metastatic gastroenteropancreatic and lung neuroendocrine tumors

Study Design

Study Type:
Observational
Anticipated Enrollment :
880 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
The Lyon Real World Evidence in Metastatic NeuroEndocrine Tumours
Actual Study Start Date :
Jul 15, 2017
Anticipated Primary Completion Date :
Jul 1, 2019
Anticipated Study Completion Date :
Jul 1, 2020

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  1. Treatments patterns in metastatic NETs patients [From diagnosis until first occurrence of each treatment, through study completion, estimated on september 2018]

    Number of interventional and systemic treatments

  2. 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

  3. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospices Civils de Lyon Lyon France 69003

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT03863106
Other Study ID Numbers:
  • LyREMeNet
First Posted:
Mar 5, 2019
Last Update Posted:
Mar 5, 2019
Last Verified:
Mar 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 5, 2019