The Lyon Real World Evidence in Metastatic NeuroEndocrine Tumours (LyREMeNet)

March 4, 2019 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

880

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Lyon, France, 69003
        • Recruiting
        • Hospices Civils de Lyon
        • Contact:
          • THOMAS WALTER, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cost in euros per year of healthcare resources related to the management of metastatic NETs patients.
Time Frame: 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)
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

Outcome Measure
Measure Description
Time Frame
Treatments patterns in metastatic NETs patients
Time Frame: From diagnosis until first occurrence of each treatment, through study completion, estimated on september 2018
Number of interventional and systemic treatments
From diagnosis until first occurrence of each treatment, through study completion, estimated on september 2018
Treatments patterns in metastatic NETs patients
Time Frame: From diagnosis until first occurrence of each treatment, through study completion, estimated on september 2018
Cumulative duration in months of systemic treatments
From diagnosis until first occurrence of each treatment, through study completion, estimated on september 2018
Overall survival
Time Frame: From the date of metastatic diagnosis of NETs to the date of death or last-follow-up, through study completion, estimated on september 2018
From the date of metastatic diagnosis of NETs to the date of death or last-follow-up, through study completion, estimated on september 2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2017

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

September 27, 2018

First Submitted That Met QC Criteria

March 4, 2019

First Posted (Actual)

March 5, 2019

Study Record Updates

Last Update Posted (Actual)

March 5, 2019

Last Update Submitted That Met QC Criteria

March 4, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LyREMeNet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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