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Spots Global Cancer Trial Database for Evolution of the Therapeutic Care in Metastatic Breast Cancer From 2008

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Trial Identification

Brief Title: Evolution of the Therapeutic Care in Metastatic Breast Cancer From 2008

Official Title: Epidemiological Strategy and Medical Economic (ESME) Research Program / Academic Real World Data Platform: Evolution of the Therapeutic Care in Metastatic Breast Cancer Across the French Comprehensive Cancer Centers From 2008

Study ID: NCT03275311

Interventions

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Centre Georges-François Leclerc, Dijon, , France

Centre Oscar Lambret, Lille, , France

Centre Léon Bérard, Lyon, , France

Institut Paoli-Calmettes, Marseille, , France

Institut régional du Cancer Montpellier / Val d'Aurelle, Montpellier, , France

Institut de Cancérologie de Lorraine, Nancy, , France

Institut de cancérologie de l'Ouest - René Gauducheau, Nantes, , France

Centre Antoine Lacassagne, Nice, , France

Institut Curie, Paris, , France

Institut Jean Godinot, Reims, , France

Centre Eugène Marquis, Rennes, , France

Centre Henri Becquerel, Rouen, , France

Institut Curie - Hôpital René Huguenin, Saint-Cloud, , France

Centre Paul Strauss, Strasbourg, , France

Institut Claudius Regaud, Toulouse, , France

Institut Gustave Roussy, Villejuif, , France

Contact Details

Name: Mathieu Robain, MD, PhD

Affiliation: UNICANCER

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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