Clinical trial NCT03848052: Evolution of the Therapeutic Care in Lung Cancer in France Since 2015 (ESME LC)
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Keywords: lung cancer
observational study
survival
real world data
real life setting
Lead sponsor: UNICANCER
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: Merck Sharp & Dohme LLC
name: Roche Pharma AG
name: Pfizer
name: Bristol-Myers Squibb
name: Janssen, LP
name: Amgen
name: Daiichi Sankyo
name: Pierre Fabre Medicament
name: QUINTEN HEALTH
First posted: 2019-02-20
Enrollment: 70000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients treated for lung cancer at one of the 38 French participating sites (Private comprehensive cancer centers and public hospitals).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient characteristics
timeFrame: Baseline
measure: Tumor characteristics
timeFrame: Baseline
measure: Treatment patterns
timeFrame: From Baseline until 2024 (yearly basis)
Secondary outcomes:
measure: Median overall survival
timeFrame: From date of diagnosis or first treatment until the date of death from any cause. Follow up until 2024
measure: Median surrogate endpoints for overall survival
timeFrame: From start date of the nth treatment line until the date of first applicable event. Follow up until 2024
Other outcomes:
Locations:
city: Angers,
country: France
facility: Institut de Cancérologie de l'Ouest - Paul Papin
city: Bordeaux
country: France
facility: Institut Bergonié
city: Caen
country: France
facility: Centre François Baclesse
city: Clermont-ferrand
country: France
facility: Centre Jean Perrin
city: Creteil
country: France
facility: Hôpital Intercommunal de Créteil
city: Dijon
country: France
facility: Centre Georges-François Leclerc
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Montpellier
country: France
facility: Institut régional du Cancer Montpellier / Val d'Aurelle
city: Mulhouse
country: France
facility: Groupe Hospitalier Région Mulhouse et Sud Alsace - Hôpital Emile Muller
city: Nantes
country: France
facility: Institut de cancérologie de l'Ouest - René Gauducheau
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Institut Curie
city: Reims
country: France
facility: Institut Jean Godinot
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint-Cloud
country: France
facility: Institut Curie - Hôpital René Huguenin
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: UNICANCER
name: Anne-Laure Martin, Pharmacist
role: STUDY_DIRECTOR
References:
citation: Robain M, Pérol M, Girard N, Debieuvre D, Coudert B, Madroszyk A, et al. Programme épidémio-stratégie médicoéconomique : une base nationale de données de vie réelle pour mieux comprendre la prise en charge du cancer bronchopulmonaire en France. Revue des Maladies Respiratoires. 2018 Jan;35:A106.
citation: Girard, N., M. Pérol, G. Simon, C. Audigier Valette, R. Gervais, D. Debieuvre, R. Schott, et al. " 90P - Real-world treatment patterns, clinical practice and outcomes for locally advanced, non resectable, non-small cell lung cancer from the French ESME Lung database ". Abstract Book of the European Lung Cancer Congress (ELCC) 10-13 April 2019, Geneva, Switzerland 30 (1 avril 2019): ii34. https://doi.org/10.1093/annonc/mdz067.006.
citation: Chouaid C, Filleron T, Debieuvre D, Perol M, Girard N, Dansin E, Lena H, Gervais R, Cousin S, Otto J, Schott R, Planchard D, Madroszyk A, Kaderbhai C, Dubray-Longeras P, Hiret S, Pichon E, Clement-Duchene C, Chenuc G, Simon G, Bosquet L, QUantin X. A Real-World Study of Patients with Advanced Non-squamous Non-small Cell Lung Cancer with EGFR Exon 20 Insertion: Clinical Characteristics and Outcomes. Target Oncol. 2021 Nov;16(6):801-811. doi: 10.1007/s11523-021-00848-9. Epub 2021 Oct 18.
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citation: Griesinger F, Perol M, Girard N, Durand-Zaleski I, Zacharias S, Bosquet L, Janicke M, Quantin X, Groth A, Fleitz A, Calleja A, Patel S, Lacoin L, Daumont MJ, Penrod JR, Carroll R, Waldenberger D, Reynaud D, Thomas M, Chouaid C. Impact of immune checkpoint inhibitors on the management of locally advanced or metastatic non-small cell lung cancer in real-life practice in patients initiating treatment between 2015 and 2018 in France and Germany. Lung Cancer. 2022 Oct;172:65-74. doi: 10.1016/j.lungcan.2022.08.001. Epub 2022 Aug 6.
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citation: Bringuier M, Carton M, Debieuvre D, Pasquier D, Perol M, Filleron T, Lena H, Quantin X, Simon G, Baldini C. Enrolment of older adults with advanced or metastatic non-small cell lung cancer in first-line clinical trials in the multicentre ESME cohort. J Geriatr Oncol. 2023 Mar;14(2):101423. doi: 10.1016/j.jgo.2022.101423. Epub 2023 Jan 17.
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citation: Belaroussi Y, Bouteiller F, Bellera C, Pasquier D, Perol M, Debieuvre D, Filleron T, Girard N, Schott R, Mathoulin-Pelissier S, Martin AL, Cousin S. Survival outcomes of patients with metastatic non-small cell lung cancer receiving chemotherapy or immunotherapy as first-line in a real-life setting. Sci Rep. 2023 Jun 13;13(1):9584. doi: 10.1038/s41598-023-36623-1.
citation: Valette CA, Filleron T, Debieuvre D, Lena H, Perol M, Chouaid C, Simon G, Quantin X, Girard N. Treatment patterns and clinical outcomes of extensive stage small cell lung cancer (SCLC) in the real-world evidence ESME cohort before the era of immunotherapy. Respir Med Res. 2023 Nov;84:101012. doi: 10.1016/j.resmer.2023.101012. Epub 2023 Mar 27.
citation: Heudel PE, de Montfort A, Debieuvre D, Chouaid C, Carton M, Audigier-Valette C, Filleron T, Chabaud S, Stancu A, Quantin X, Hiret S, Bosquet L, Blay JY. Reduced risk of secondary primary extra pulmonary cancer in advanced/metastatic lung cancer patients treated with immune checkpoint inhibitors. Lung Cancer. 2023 Aug;182:107280. doi: 10.1016/j.lungcan.2023.107280. Epub 2023 Jun 16.
citation: Thomas QD, Quantin X, Lemercier P, Chouaid C, Schneider S, Filleron T, Remon-Masip J, Perol M, Debieuvre D, Audigier-Valette C, Justeau G, Loeb A, Hiret S, Clement-Duchene C, Dansin E, Stancu A, Pichon E, Bosquet L, Girard N, Du Rusquec P. Clinical characteristic and survival outcomes of patients with advanced NSCLC according to KRAS mutational status in the French real-life ESME cohort. ESMO Open. 2024 Jun;9(6):103473. doi: 10.1016/j.esmoop.2024.103473. Epub 2024 Jun 3.
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citation: Thomas QD, Girard N, Bosquet L, Cavaillon S, Filleron T, Eltaief S, Chouaid C, Lena H, Debieuvre D, Perol M, Quantin X. Optimizing Treatment Strategies for Egfr-Mutated Non-Small-Cell Lung Cancer Treated with Osimertinib: Real-World Outcomes and Insights. Cancers (Basel). 2024 Oct 23;16(21):3563. doi: 10.3390/cancers16213563.