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

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ClinicalTrials.gov Identifier: NCT03863106
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date September 27, 2018
First Posted Date March 5, 2019
Last Update Posted Date March 5, 2019
Actual Study Start Date July 15, 2017
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 4, 2019)
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) ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 4, 2019)
  • 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
  • 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
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Lyon Real World Evidence in Metastatic NeuroEndocrine Tumours
Official Title The Lyon Real World Evidence in Metastatic NeuroEndocrine Tumours
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Gastro-enteropancreatic Neuroendocrine Tumor
  • Health Care Costs
  • Metastatic Cancer
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.
Other Name: Metastatic NETs population description Healthcare resources use and related cost Clinical parameter: Demographic and tumour characteristics, treatments patterns
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 4, 2019)
880
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2020
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 15 Years to 100 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: THOMAS WALTER, Dr +33 (0) 4 72 11 73 98 thomas.walter@chu-lyon.fr
Contact: EMILIE PROME +33 (0) 4 72 11 62 03 emilie.prome@chu-lyon.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03863106
Other Study ID Numbers LyREMeNet
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor Hospices Civils de Lyon
Collaborators Not Provided
Investigators Not Provided
PRS Account Hospices Civils de Lyon
Verification Date March 2019