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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- UNICANCER
- Enrollment
- 75,000
- Locations
- 21
- Primary Endpoint
- Patient characteristics
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
- Not provided
Outcomes
Primary Outcomes
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)
Tumor characteristics
Time Frame: Baseline
Staging, Tumor size, sampling Method, histological type
Treatment patterns
Time Frame: From Baseline until 2024 (yearly basis)
Drug, therapeutic class, treatment duration at each n treatment line
Secondary Outcomes
- 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)