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

Lung Cancer Clinical Trial

Official title:
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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03848052
Study type Observational
Source UNICANCER
Contact Lise Bosquet, MsC
Phone 0033668642660
Email l-bosquet@unicancer.fr
Status Recruiting
Phase
Start date October 2, 2017
Completion date December 31, 2024
View Details
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