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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03848052
• Other study ID #: ESME LC
• Status: Recruiting
• Start date: October 2, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: UNICANCER
• Contact: Lise Bosquet, MsC
• Phone: 0033668642660
• Email: l-bosquet[@]unicancer.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 51000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
France	Institut de Cancérologie de l'Ouest - Paul Papin	Angers,
France	Institut Bergonié	Bordeaux
France	Centre François Baclesse	Caen
France	Centre Jean Perrin	Clermont-ferrand
France	Hôpital Intercommunal de Créteil	Creteil
France	Centre Georges-François Leclerc	Dijon
France	Centre Oscar Lambret	Lille
France	Centre Léon Bérard	Lyon
France	Institut Paoli-Calmettes	Marseille
France	Institut régional du Cancer Montpellier / Val d'Aurelle	Montpellier
France	Groupe Hospitalier Région Mulhouse et Sud Alsace - Hôpital Emile Muller	Mulhouse
France	Institut de cancérologie de l'Ouest - René Gauducheau	Nantes
France	Centre Antoine Lacassagne	Nice
France	Institut Curie	Paris
France	Institut Jean Godinot	Reims
France	Centre Henri Becquerel	Rouen
France	Institut Curie - Hôpital René Huguenin	Saint-Cloud
France	Centre Paul Strauss	Strasbourg
France	Institut Claudius Regaud	Toulouse
France	Institut de Cancérologie de Lorraine	Vandœuvre-lès-Nancy
France	Institut Gustave Roussy	Villejuif

Sponsors (10)

Lead Sponsor	Collaborator
UNICANCER	Amgen, AstraZeneca, Bristol-Myers Squibb, Daiichi Sankyo, Inc., Janssen, LP, Merck Sharp & Dohme LLC, Pfizer, Roche Pharma AG, Sanofi

Country where clinical trial is conducted

France, 

References & Publications (11)

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 immunot — View 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 Ge — View Citation

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 — View 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 — View Citation

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 — View 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 Lu

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 — View 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 t — View Citation

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 Fren — View 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.

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 — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient characteristics	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)	Baseline
Primary	tumor characteristics	Staging, Tumor size, sampling Method, histological type	Baseline
Primary	treatment patterns	Drug, therapeutic class, treatment duration at each n treatment line	From Baseline until 2024 (yearly basis)
Secondary	Median overall survival	Assessment of overall survival through treatment lines	From date of diagnosis or first treatment until the date of death from any cause. Follow up until 2024
Secondary	Median surrogate endpoints for overall survival	Surrogate endpoints (Progression-free Survival, Time to Progression, Time to Next Treatment) at each n treatment line.	From start date of the nth treatment line until the date of first applicable event. Follow up until 2024