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Trial record 73 of 1297 for:    survival | Neuroendocrine Tumors

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

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
Gastro-enteropancreatic Neuroendocrine Tumor Health Care Costs Metastatic Cancer Other: Metastatic gastroenteropancreatic and lung neuroendocrine tumors

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



Intervention Details:
  • 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


Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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 ]


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Ages Eligible for Study:   15 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03863106


Contacts
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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

Locations
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France
Hospices Civils de Lyon Recruiting
Lyon, France, 69003
Contact: THOMAS WALTER, Dr         
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03863106     History of Changes
Other Study ID Numbers: LyREMeNet
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neoplasm Metastasis
Intestinal Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Neoplastic Processes
Pathologic Processes
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Pancreatic Diseases
Endocrine System Diseases
Stomach Diseases