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Recruiting NCT03848052

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

— Observational Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Primary outcome measures

  • Patient characteristics [Time frame: Baseline]
  • Tumor characteristics [Time frame: Baseline]
  • Treatment patterns [Time frame: From Baseline until 2024 (yearly basis)]
Secondary outcome measures (2)
  • Median overall survival [Time frame: From date of diagnosis or first treatment until the date of death from any cause. Follow up until 2024]
  • Median surrogate endpoints for overall survival [Time frame: From start date of the nth treatment line until the date of first applicable event. Follow up until 2024]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 21 centers
  • Institut de Cancérologie de l'Ouest - Paul Papin — Angers
  • Institut Bergonié — Bordeaux
  • Centre François Baclesse — Caen
  • Centre Jean Perrin — Clermont-Ferrand
  • Hôpital Intercommunal de Créteil — Créteil
  • Centre Georges-François Leclerc — Dijon
  • Centre Oscar Lambret — Lille
  • Centre Léon Bérard — Lyon
  • … and 13 more centers

Publications

  • 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.
  • 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://d
  • 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 PMID 34661827
  • 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. PMID 35008257
  • 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 PMID 36007281
  • 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 C PMID 36551632
  • 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. PMID 36657245
  • 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 PMID 36652175

Identifiers

NCT: NCT03848052 · ESME LC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗