Lung Cancer
Conditions
Keywords
lung cancer, observational study, survival, real world data, real life setting
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).
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.
Interventions
None listed
Sponsors
UNICANCER
AstraZeneca
Merck Sharp & Dohme LLC
Roche Pharma AG
Pfizer
Bristol-Myers Squibb
Janssen, LP
Amgen
Daiichi Sankyo
Pierre Fabre Medicament
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient characteristics | 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) |
| Tumor characteristics | Baseline | Staging, Tumor size, sampling Method, histological type |
| Treatment patterns | From Baseline until 2024 (yearly basis) | Drug, therapeutic class, treatment duration at each n treatment line |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median overall survival | 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 |
| 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 | Surrogate endpoints (Progression-free Survival, Time to Progression, Time to Next Treatment) at each n treatment line. |
Countries
France
Contacts
CONTACTLise Bosquet, MsC
CONTACTMathieu Robain, MD, PhD
STUDY_DIRECTORAnne-Laure Martin, Pharmacist
UNICANCER
Outcome results
None listed