ESME-MBC: Evolution of the Therapeutic Care in Metastatic Breast Cancer From 2008
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- Describe the evolution of therapeutic care [baseline]
Patient characteristics, tumor characteristics and treatment patterns
Secondary Outcome Measures
- 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 2020.]
Overall survival
- 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 2020.]
Progression free survival
Eligibility Criteria
Criteria
Inclusion criteria :
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18 years old patient
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Patient receiving chemotherapy, targeted therapy, immunotherapy, radiation therapy and hormonotherapy in a French Comprehensive Cancer Center.
Exclusion criteria : None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institut de Cancérologie de l'Ouest - Paul Papin | Angers | France | 49933 | |
| 2 | Institut Bergonié | Bordeaux | France | 33076 | |
| 3 | Centre François Baclesse | Caen | France | 14076 | |
| 4 | Centre Jean Perrin | Clermont-ferrand | France | 63011 | |
| 5 | Centre Georges-François Leclerc | Dijon | France | 21079 | |
| 6 | Centre Oscar Lambret | Lille | France | 59020 | |
| 7 | Centre Léon Bérard | Lyon | France | 69373 | |
| 8 | Institut Paoli-Calmettes | Marseille | France | 13273 | |
| 9 | Institut régional du Cancer Montpellier / Val d'Aurelle | Montpellier | France | 34298 | |
| 10 | Institut de Cancérologie de Lorraine | Nancy | France | ||
| 11 | Institut de cancérologie de l'Ouest - René Gauducheau | Nantes | France | 44805 | |
| 12 | Centre Antoine Lacassagne | Nice | France | 06189 | |
| 13 | Institut Curie | Paris | France | 75005 | |
| 14 | Institut Jean Godinot | Reims | France | 51056 | |
| 15 | Centre Eugène Marquis | Rennes | France | 35042 | |
| 16 | Centre Henri Becquerel | Rouen | France | 76038 | |
| 17 | Institut Curie - Hôpital René Huguenin | Saint-Cloud | France | 92210 | |
| 18 | Centre Paul Strauss | Strasbourg | France | 67065 | |
| 19 | Institut Claudius Regaud | Toulouse | France | 31059 | |
| 20 | Institut Gustave Roussy | Villejuif | France | 94805 |
Sponsors and Collaborators
- UNICANCER
- Roche Pharma AG
- Pierre Fabre Laboratories
- Pfizer
- AstraZeneca
- Merck Sharp & Dohme LLC
- Eisai Inc.
- Daiichi Sankyo, Inc.
- Eli Lilly and Company
- Gilead Sciences
- Seagen Inc.
Investigators
- Study Director: Mathieu Robain, MD, PhD, UNICANCER
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ESMEMBC