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NCT Number: NCT03848052

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

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut de Cancérologie de l'Ouest - Paul Papin, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Patient characteristics

    Time frame: Baseline

    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)

  2. Tumor characteristics

    Time frame: Baseline

    Staging, Tumor size, sampling Method, histological type

  3. Treatment patterns

    Time frame: From Baseline until 2024 (yearly basis)

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

Secondary outcomes

  1. Median overall survival

    Time frame: From date of diagnosis or first treatment until the date of death from any cause. Follow up until 2024

    Assessment of overall survival through treatment lines

  2. 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

    Surrogate endpoints (Progression-free Survival, Time to Progression, Time to Next Treatment) at each n treatment line.

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Bosquet, MsC

CONTACT

[email protected]

0033668642660

Mathieu Robain, MD, PhD

CONTACT

[email protected]

0033144235553

Sponsors and collaborators

Lead sponsor

UNICANCER

Other

Collaborators

  • Amgen
  • AstraZeneca
  • Boehringer Ingelheim
  • Bristol-Myers Squibb
  • Daiichi Sankyo
  • Janssen, LP
  • Merck Sharp & Dohme LLC
  • Pfizer
  • Pierre Fabre Medicament
  • Roche Pharma AG

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2025
Study completion
2026
First posted
Feb 20, 2019
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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