Evolution of the Therapeutic Care in Ovarian Cancer From 2011 (ESME-OVR)
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|ClinicalTrials.gov Identifier: NCT03275298|
Recruitment Status : Recruiting
First Posted : September 7, 2017
Last Update Posted : February 20, 2019
|Condition or disease|
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 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 OVR Data Platform aims to be a clinical and therapeutic database centralising existing and available data from different sources used in the FCCCs.
|Study Type :||Observational|
|Estimated Enrollment :||14000 participants|
|Official Title:||Epidemiological Strategy and Medical Economic (ESME) Research Program / Academic Real World Data Platform : Evolution of the Therapeutic Care in Ovarian Cancer Across the French Comprehensive Cancer Centers From 2011|
|Actual Study Start Date :||April 1, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2022|
- Describe the evolution of therapeutic care in ovarian cancer across the French comprehensive cancer centers [ Time Frame: baseline ]Patient characteristics, tumor characteristics and treatment patterns
- Describe the impact of therapeutic strategies on survival criteria [ Time Frame: From date of diagnosis or first treatment until the date of date of death from any cause. Follow up until 2022. ]Overall survival
- Describe the impact of therapeutic strategies on survival criteria [ Time Frame: From date of diagnosis or first treatment until the date of first documented progression or date of death from any cause. Follow up until 2022. ]Progression free survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03275298
|Contact: Mathieu Robain, MD, PhD||+ 33 1 44 23 55 email@example.com|
|Contact: Coralie Courtinard, Msc||+33 1 85 34 33 firstname.lastname@example.org|
|Study Director:||Mathieu Robain, MD, PhD||UNICANCER|