Evolution of the Therapeutic Care in Metastatic Breast Cancer From 2008
- Conditions
- Metastatic Breast Cancer
- Registration Number
- NCT03275311
- Lead Sponsor
- UNICANCER
- Brief Summary
The Epidemiological Strategy and Medical Economic (ESME) Ovarian cancer Data Platform is a multi-center real life database using a retrospective data collection process (18 FCCCs over 20 sites). This database compiles data from Patient's Electronic medical records (EMR), inpatient Hospitalisation records and Pharmacy records.
- Detailed 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 French Comprehensive Cancer Centers (FCCC), 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 FCCC, 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 MBC Data Platform aims to be a clinical and therapeutic database centralising existing and available data from different sources used in the FCCCs.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 38000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Describe the evolution of therapeutic care baseline Patient characteristics, tumor characteristics and treatment patterns
- Secondary Outcome Measures
Name Time Method Describe the impact of therapeutic strategies on survival criteria From date of diagnosis or first treatment until the date of first documented progression or date of death from any cause. Follow up until 2023. Progression free survival
Trial Locations
- Locations (20)
Institut Bergonié
🇫🇷Bordeaux, France
Institut de Cancérologie de l'Ouest - Paul Papin
🇫🇷Angers, France
Centre François Baclesse
🇫🇷Caen, France
Centre Jean Perrin
🇫🇷Clermont-ferrand, France
Centre Léon Bérard
🇫🇷Lyon, France
Centre Georges-François Leclerc
🇫🇷Dijon, France
Centre Oscar Lambret
🇫🇷Lille, France
Institut Paoli-Calmettes
🇫🇷Marseille, France
Institut régional du Cancer Montpellier / Val d'Aurelle
🇫🇷Montpellier, France
Institut de cancérologie de l'Ouest - René Gauducheau
🇫🇷Nantes, France
Institut Curie
🇫🇷Paris, France
Centre Henri Becquerel
🇫🇷Rouen, France
Centre Eugène Marquis
🇫🇷Rennes, France
Institut Curie - Hôpital René Huguenin
🇫🇷Saint-Cloud, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Centre Paul Strauss
🇫🇷Strasbourg, France
Institut Claudius Regaud
🇫🇷Toulouse, France
Institut de Cancérologie de Lorraine
🇫🇷Nancy, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Institut Jean Godinot
🇫🇷Reims, France