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Trial record 1 of 2 for:    NCT03275311
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Evolution of the Therapeutic Care in Metastatic Breast Cancer From 2008 (ESME-MBC)

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ClinicalTrials.gov Identifier: NCT03275311
Recruitment Status : Recruiting
First Posted : September 7, 2017
Last Update Posted : February 20, 2019
Sponsor:
Collaborators:
Roche Pharma AG
Pierre Fabre Laboratories
Pfizer
AstraZeneca
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
UNICANCER

Tracking Information
First Submitted Date June 27, 2017
First Posted Date September 7, 2017
Last Update Posted Date February 20, 2019
Actual Study Start Date October 27, 2014
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 5, 2017)
Describe the evolution of therapeutic care [ Time Frame: baseline ]
Patient characteristics, tumor characteristics and treatment patterns
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 5, 2017)
  • 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 2020. ]
    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 2020. ]
    Progression free survival
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Metastatic Breast Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 5, 2017)
30000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Mathieu Robain, MD, PhD m-robain@unicancer.fr
Contact: Gaëtane Simon, Msc g-simon@unicancer.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03275311
Other Study ID Numbers ESMEMBC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party UNICANCER
Study Sponsor UNICANCER
Collaborators
  • Roche Pharma AG
  • Pierre Fabre Laboratories
  • Pfizer
  • AstraZeneca
  • Merck Sharp & Dohme Corp.
Investigators
Study Director: Mathieu Robain, MD, PhD UNICANCER
PRS Account UNICANCER
Verification Date February 2019