Evolution of the Therapeutic Care in Lung Cancer in France Since 2015 (ESME LC)

Study Overview
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Brief Summary
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The ESME LC Data Platform is a multicenter real life database using a retrospective data collection process in France over 38 sites. This database compiles data from Patient's Electronic medical records (EMR), inpatient Hospitalisation records and Pharmacy records.

Detailed Description
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This database compiles data from Patient's Electronic medical records (EMR), inpatient Hospitalisation records and Pharmacy records. Patient Database: Patient-related data integrates data from non-structured sources (electronic medical records), such as patient medical records and reports of multidiscipline team meetings. It can provide information on patient demographics, primitive tumour, relapses, pathology reports, metastatic disease, therapeutic care/settings and withdrawal reasons when applicable and clinical events. Treatment Database: Pharmacy records-related data is a structured database including all data pertaining to medications prescribed and dispensed by pharmacies within each center, specifically chemotherapy and co-prescriptions. It does not contain information on products that are prescribed or delivered outside of the center. From each center's pharmacy database, information on systemic treatment patterns (dates, pharmaceutical forms, treatment protocols, etc.) can be obtained. Hospitalization Database: Hospitalisation-related data is a structured and systematic database that contains all medical data reported related to any hospitalisation in the contributing center, and is used to bill the French National Health Insurance Fund (Assurance Maladie). It provides information on patient entry and discharge dates as well as diagnostic and therapeutic procedures performed, including radiotherapy and surgery. Data imported into the final database are controlled, recoded, and harmonized before import according to a data management plan. All coding procedures are predefined by the data manager. There is no transmission of individual data; all data are centralized within each center using a shared anonymous format. All data are exclusively obtained retrospectively; no attempts are made to recover non available data from the patient's medical record by contacting healthcare providers or patients. ESME LC Data Platform aims to be a clinical and therapeutic database centralising existing and available data from different sources used in the participating sites.

Official Title
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Epidemiological Strategy and Medical Economic (ESME) Research Program / Academic Real World Data Platform: Evolution of the Therapeutic Care in Lung Cancer in France Since 2015

Conditions
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Lung Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion criteria : Adult (over 18) Treated (with radiotherapy or systemic anti-cancer treatment) for a lung cancer or diagnosed with metastatic lung cancer over the selection period at one of the participating site Exclusion criteria - None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient characteristics | Aage in years, Tobacco consumption, other exposures, Legal recognition as occupational disease, Medical history, History of other cancer, weight in kg and performance status (ECOG) | Baseline | 
| tumor characteristics | Staging, Tumor size, sampling Method, histological type | Baseline | 
| treatment patterns | Drug, therapeutic class, treatment duration at each n treatment line | From Baseline until 2024 (yearly basis) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median overall survival | Assessment of overall survival through treatment lines | From date of diagnosis or first treatment until the date of death from any cause. Follow up until 2024 | 
| Median surrogate endpoints for overall survival | Surrogate endpoints (Progression-free Survival, Time to Progression, Time to Next Treatment) at each n treatment line. | From start date of the nth treatment line until the date of first applicable event. Follow up until 2024 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer, observational study, survival, real world data, real life setting