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

Recruiting
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
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
tumor characteristicsBaseline

Staging, Tumor size, sampling Method, histological type

Patient characteristicsBaseline

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 patternsFrom Baseline until 2024 (yearly basis)

Drug, therapeutic class, treatment duration at each n treatment line

Secondary Outcome Measures
NameTimeMethod
Median overall survivalFrom 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 survivalFrom 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

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