Evolution of the Therapeutic Care in Ovarian Cancer From 2011
- Conditions
- Ovarian Cancer
- Registration Number
- NCT03275298
- Lead Sponsor
- UNICANCER
- Brief Summary
The ESME Ovarian Cancer database is a multi-center real life database using a retrospective data collection process in 18 French Comprehensive Cancer Center (FCCC) over 20 sites). This database compiles data from existing data available from patient's electronic medical records (EMR).
- Detailed Description
This database compiles data from existing data available from patient's electronic medical records (EMR) and integrates data from non-structured ans structured sources.
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 OC database aims to be a clinical and therapeutic database centralizing existing and available data from different sources used in the participating hospitals. 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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- Female
- Target Recruitment
- 13331
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 in ovarian cancer across the French comprehensive cancer centers 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 date of death from any cause. Follow up until 2022. Overall survival
Trial Locations
- Locations (20)
Centre Paul Strauss
🇫🇷Strasbourg, France
Centre Léon Bérard
🇫🇷Lyon, France
Centre Georges-François Leclerc
🇫🇷Dijon, France
Institut de cancérologie de l'Ouest - René Gauducheau
🇫🇷Nantes, France
Institut Curie
🇫🇷Paris, France
Institut Paoli-Calmettes
🇫🇷Marseille, France
Institut régional du Cancer Montpellier / Val d'Aurelle
🇫🇷Montpellier, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Centre Oscar Lambret
🇫🇷Lille, France
Centre Eugène Marquis
🇫🇷Rennes, France
Institut de Cancérologie de Lorraine
🇫🇷Nancy, France
Institut Curie - Hôpital René Huguenin
🇫🇷Saint-Cloud, France
Institut Claudius Regaud
🇫🇷Toulouse, 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
Institut Jean Godinot
🇫🇷Reims, France
Centre Henri Becquerel
🇫🇷Rouen, France