NCT03848052

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Longer than P75 for all trials

Geographic Reach
1 country

21 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2018

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2024

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 17, 2025

Status Verified

December 1, 2024

Enrollment Period

7 years

First QC Date

January 25, 2018

Last Update Submit

January 15, 2025

Conditions

Lung Cancer

Keywords

lung cancerobservational studysurvivalreal world datareal life setting

Outcome Measures

Primary Outcomes (3)

  • Patient characteristics

    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)

    Baseline

  • Tumor characteristics

    Staging, Tumor size, sampling Method, histological type

    Baseline

  • Treatment patterns

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

    From Baseline until 2024 (yearly basis)

Secondary Outcomes (2)

  • Median overall survival

    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

    From start date of the nth treatment line until the date of first applicable event. Follow up until 2024

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Institut de Cancérologie de l'Ouest - Paul Papin

Angers, 49933, France

RECRUITING

Institut Bergonié

Bordeaux, 33076, France

RECRUITING

Centre François Baclesse

Caen, 14076, France

RECRUITING

Centre Jean Perrin

Clermont-Ferrand, 63011, France

RECRUITING

Hôpital Intercommunal de Créteil

Créteil, 94000, France

RECRUITING

Centre Georges-François Leclerc

Dijon, 21079, France

RECRUITING

Centre Oscar Lambret

Lille, 59020, France

RECRUITING

Centre Léon Bérard

Lyon, 69373, France

RECRUITING

Institut Paoli-Calmettes

Marseille, 13273, France

RECRUITING

Institut régional du Cancer Montpellier / Val d'Aurelle

Montpellier, 34298, France

RECRUITING

Groupe Hospitalier Région Mulhouse et Sud Alsace - Hôpital Emile Muller

Mulhouse, 68070, France

RECRUITING

Institut de cancérologie de l'Ouest - René Gauducheau

Nantes, 44805, France

RECRUITING

Centre Antoine Lacassagne

Nice, 06189, France

RECRUITING

Institut Curie

Paris, 75005, France

RECRUITING

Institut Jean Godinot

Reims, 51056, France

RECRUITING

Centre Henri Becquerel

Rouen, 76038, France

RECRUITING

Institut Curie - Hôpital René Huguenin

Saint-Cloud, 92210, France

RECRUITING

Centre Paul Strauss

Strasbourg, 67065, France

RECRUITING

Institut Claudius Regaud

Toulouse, 31059, France

RECRUITING

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

RECRUITING

Institut Gustave Roussy

Villejuif, 94805, France

RECRUITING

Related Publications (14)

  • 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.

    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.

    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.

    PMID: 34661827RESULT

  • 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: 35008257RESULT

  • 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.

    PMID: 36007281RESULT

  • 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.

    PMID: 36551632RESULT

  • 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: 36657245RESULT

  • 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.

    PMID: 36652175RESULT

  • 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.

    PMID: 37311845RESULT

  • 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.

    PMID: 37307617RESULT

  • 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.

    PMID: 37339550RESULT

  • 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.

    PMID: 38833966RESULT

  • 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.

    PMID: 39068144RESULT

  • 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.

    PMID: 39518004RESULT

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Anne-Laure Martin, Pharmacist

    UNICANCER

    STUDY DIRECTOR

Central Study Contacts

Lise Bosquet, MsC

CONTACT

0033668642660l-bosquet@unicancer.fr

Mathieu Robain, MD, PhD

CONTACT

0033144235553m-robain@unicancer.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2018

First Posted

February 20, 2019

Study Start

October 2, 2017

Primary Completion

September 20, 2024

Study Completion

December 31, 2025

Last Updated

January 17, 2025

Record last verified: 2024-12

Locations

FR(21)