Evolution of the Therapeutic Care in Lung Cancer in France Since 2015 (ESME LC)
- Conditions
- Lung Cancer
- Registration Number
- NCT03848052
- Lead Sponsor
- UNICANCER
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 51000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method tumor characteristics Baseline Staging, Tumor size, sampling Method, histological type
Patient characteristics Baseline 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)
treatment patterns From Baseline until 2024 (yearly basis) Drug, therapeutic class, treatment duration at each n treatment line
- Secondary Outcome Measures
Name Time Method Median overall survival From date of diagnosis or first treatment until the date of death from any cause. Follow up until 2024 Assessment of overall survival through treatment lines
Median surrogate endpoints for overall survival From start date of the nth treatment line until the date of first applicable event. Follow up until 2024 Surrogate endpoints (Progression-free Survival, Time to Progression, Time to Next Treatment) at each n treatment line.
Trial Locations
- Locations (21)
Institut Bergonié
🇫🇷Bordeaux, France
Institut Paoli-Calmettes
🇫🇷Marseille, France
Groupe Hospitalier Région Mulhouse et Sud Alsace - Hôpital Emile Muller
🇫🇷Mulhouse, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Institut de Cancérologie de l'Ouest - Paul Papin
🇫🇷Angers,, France
Centre François Baclesse
🇫🇷Caen, France
Centre Jean Perrin
🇫🇷Clermont-ferrand, France
Hôpital Intercommunal de Créteil
🇫🇷Creteil, France
Centre Oscar Lambret
🇫🇷Lille, France
Centre Georges-François Leclerc
🇫🇷Dijon, France
Centre Léon Bérard
🇫🇷Lyon, France
Institut régional du Cancer Montpellier / Val d'Aurelle
🇫🇷Montpellier, France
Institut de cancérologie de l'Ouest - René Gauducheau
🇫🇷Nantes, France
Institut Jean Godinot
🇫🇷Reims, France
Centre Henri Becquerel
🇫🇷Rouen, France
Institut Curie
🇫🇷Paris, France
Institut Curie - Hôpital René Huguenin
🇫🇷Saint-Cloud, France
Centre Paul Strauss
🇫🇷Strasbourg, France
Institut de Cancérologie de Lorraine
🇫🇷Vandœuvre-lès-Nancy, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Institut Claudius Regaud
🇫🇷Toulouse, France