Evolution of the Therapeutic Care in Lung Cancer in France Since 2015 (ESME LC)
NCT ID: NCT03848052
Last Updated: 2025-01-17
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
70000 participants
Study Classification
OBSERVATIONAL
Study Start Date
2017-10-02
Study Completion Date
2025-12-31
Brief Summary
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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).
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Detailed Description
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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.
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.
Conditions
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Lung Cancer
Study Design
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Observational Model Type
COHORT
Study Time Perspective
RETROSPECTIVE
Eligibility Criteria
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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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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AstraZeneca
INDUSTRY
Sponsor Role
collaborator
Merck Sharp & Dohme LLC
INDUSTRY
Sponsor Role
collaborator
Roche Pharma AG
INDUSTRY
Sponsor Role
collaborator
Pfizer
INDUSTRY
Sponsor Role
collaborator
Bristol-Myers Squibb
INDUSTRY
Sponsor Role
collaborator
Janssen, LP
INDUSTRY
Sponsor Role
collaborator
Amgen
INDUSTRY
Sponsor Role
collaborator
Daiichi Sankyo
INDUSTRY
Sponsor Role
collaborator
Pierre Fabre Medicament
INDUSTRY
Sponsor Role
collaborator
QUINTEN HEALTH
UNKNOWN
Sponsor Role
collaborator
UNICANCER
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Anne-Laure Martin, Pharmacist
Role: STUDY_DIRECTOR
UNICANCER
Locations
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Institut de Cancérologie de l'Ouest - Paul Papin
Angers, , France
Site Status
RECRUITING
Institut Bergonié
Bordeaux, , France
Site Status
RECRUITING
Centre François Baclesse
Caen, , France
Site Status
RECRUITING
Centre Jean Perrin
Clermont-Ferrand, , France
Site Status
RECRUITING
Hôpital Intercommunal de Créteil
Créteil, , France
Site Status
RECRUITING
Centre Georges-François Leclerc
Dijon, , France
Site Status
RECRUITING
Centre Oscar Lambret
Lille, , France
Site Status
RECRUITING
Centre Léon Bérard
Lyon, , France
Site Status
RECRUITING
Institut Paoli-Calmettes
Marseille, , France
Site Status
RECRUITING
Institut régional du Cancer Montpellier / Val d'Aurelle
Montpellier, , France
Site Status
RECRUITING
Groupe Hospitalier Région Mulhouse et Sud Alsace - Hôpital Emile Muller
Mulhouse, , France
Site Status
RECRUITING
Institut de cancérologie de l'Ouest - René Gauducheau
Nantes, , France
Site Status
RECRUITING
Centre Antoine Lacassagne
Nice, , France
Site Status
RECRUITING
Institut Curie
Paris, , France
Site Status
RECRUITING
Institut Jean Godinot
Reims, , France
Site Status
RECRUITING
Centre Henri Becquerel
Rouen, , France
Site Status
RECRUITING
Institut Curie - Hôpital René Huguenin
Saint-Cloud, , France
Site Status
RECRUITING
Centre Paul Strauss
Strasbourg, , France
Site Status
RECRUITING
Institut Claudius Regaud
Toulouse, , France
Site Status
RECRUITING
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, , France
Site Status
RECRUITING
Institut Gustave Roussy
Villejuif, , France
Site Status
RECRUITING
Countries
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France
Central Contacts
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Facility Contacts
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References
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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.
Reference Type
BACKGROUND
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.
Reference Type
RESULT
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.
Reference Type
RESULT
Lamy T, Cabarrou B, Planchard D, Quantin X, Schneider S, Bringuier M, Besse B, Girard N, Chouaid C, Filleron T, Simon G, Baldini C. Biomarker Testing in Older Patients Treated for an Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer: The French ESME Real-Life Multicenter Cohort Experience. Cancers (Basel). 2021 Dec 24;14(1):92. doi: 10.3390/cancers14010092.
Reference Type
RESULT
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.
Reference Type
RESULT
Chouaid C, Thomas M, Debieuvre D, Durand-Zaleski I, Zacharias S, Bosquet L, Groth A, Fleitz A, Calleja A, Patel S, Lacoin L, Daumont MJ, Penrod JR, Carroll R, Waldenberger D, Cotte FE, Audigier-Valette C, Griesinger F. Effectiveness of Nivolumab in Second-Line and Later in Patients with Advanced Non-Small Cell Lung Cancer in Real-Life Practice in France and Germany: Analysis of the ESME-AMLC and CRISP Cohorts. Cancers (Basel). 2022 Dec 13;14(24):6148. doi: 10.3390/cancers14246148.
Reference Type
RESULT
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.
Reference Type
RESULT
Chouaid C, Bosquet L, Girard N, Kron A, Scheffler M, Griesinger F, Sebastian M, Trigo J, Viteri S, Knott C, Rodrigues B, Rahhali N, Cabrieto J, Diels J, Perualila NJ, Schioppa CA, Sermon J, Toueg R, Erdmann N, Mielke J, Nematian-Samani M, Martin-Fernandez C, Pfaira I, Li T, Mahadevia P, Wolf J. An Adjusted Treatment Comparison Comparing Amivantamab Versus Real-World Clinical Practice in Europe and the United States for Patients with Advanced Non-Small Cell Lung Cancer with Activating Epidermal Growth Factor Receptor Exon 20 Insertion Mutations. Adv Ther. 2023 Mar;40(3):1187-1203. doi: 10.1007/s12325-022-02408-7. Epub 2023 Jan 18.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
Cabart M, Mourey L, Pasquier D, Schneider S, Lena H, Girard N, Chouaid C, Schott R, Hiret S, Debieuvre D, Quantin X, Madroszyk A, Dubray-Longeras P, Pichon E, Baranzelli A, Justeau G, Perol M, Bosquet L, Cabarrou B. Real-world overview of therapeutic strategies and prognosis of older patients with advanced or metastatic non-small cell lung cancer from the ESME database. J Geriatr Oncol. 2024 Sep;15(7):101819. doi: 10.1016/j.jgo.2024.101819. Epub 2024 Jul 26.
Reference Type
RESULT
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.
Reference Type
RESULT
Other Identifiers
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ESME LC
Identifier Type: -
Identifier Source: org_study_id
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