Evolution of the Therapeutic Care in Metastatic Breast Cancer From 2008 (ESME-MBC)

April 18, 2024 updated by: UNICANCER

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

38000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All consecutive patients treated for a metastatic breast cancer in a French Comprehensive Cancer Center over the selection period.

Description

Inclusion criteria :

  • 18 years old patient
  • Patient receiving chemotherapy, targeted therapy, immunotherapy, radiation therapy and hormonotherapy in a French Comprehensive Cancer Center.

Exclusion criteria : None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe the evolution of therapeutic care
Time Frame: baseline
Patient characteristics, tumor characteristics and treatment patterns
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 2023.
Overall survival
From date of diagnosis or first treatment until the date of date of death from any cause. Follow up until 2023.
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 2023.
Progression free survival
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNICANCER

Collaborators

Eli Lilly and Company
Merck Sharp & Dohme LLC
Pfizer
Gilead Sciences
Roche Pharma AG
AstraZeneca
Eisai Inc.
Seagen Inc.
Pierre Fabre Laboratories
Daiichi Sankyo

Investigators

  • Study Director: Mathieu Robain, MD, PhD, UNICANCER

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

June 27, 2017

First Submitted That Met QC Criteria

September 5, 2017

First Posted (Actual)

September 7, 2017

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESMEMBC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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