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
This database compiles data from existing data available from patient's electronic medical records (EMR) at the 38 participating hospitals (20 French comprehensive cancer centers and 18 public hospitals).
- Detailed Description
The database includes data related to patient demographics, tumor characteristics (diagnosis, histology, relapses, metastatic disease, etc.), treatments (dates, INN, route of administration, treatment protocols, reason for termination, etc.), and clinical events. Data is collected at each participating site by technicians who are specifically trained for the project using an electronic data collection (eDC) tool.
Data imported into the final database are controlled, recoded, and harmonized before import according to the 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 is 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 centralizing existing and available data from different sources used in the participating sites.
Data do not contain any personal data on patients. In compliance with the authorization delivered by the French Data Protection agency to Unicancer, only aggregated statistical reports and publication are released.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment patterns From Baseline until 2024 (yearly basis) Drug, therapeutic class, treatment duration at each n treatment line
Patient characteristics Baseline Age in years, Tobacco consumption, other exposures, Legal recognition as occupational disease, Medical history, History of other cancer, weight in kg and performance status (ECOG)
Tumor characteristics Baseline Staging, Tumor size, sampling Method, histological type
- 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