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Evolution of the Therapeutic Care in Ovarian Cancer From 2011 (ESME-OVR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03275298
Recruitment Status : Recruiting
First Posted : September 7, 2017
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
UNICANCER

Brief Summary:
The ESME OVR Data Platform is a multi-center real life database using a retrospective data collection process in 18 French Comprehensive Cancer Center (FCCC) over 20 sites). This database compiles data from Patient's Electronic medical records (EMR), inpatient Hospitalisation records and Pharmacy records.

Condition or disease
Ovarian Cancer

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 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.

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Study Type : Observational
Estimated Enrollment : 14000 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All consecutive females treated for an ovarian cancer e in a French Comprehensive Cancer Center over the selection period.
Criteria

Inclusion criteria :

  • 18 years old female
  • Female receiving surgery, chemotherapy, targeted therapy, immunotherapy, radiation therapy, diagnostic procedure, other specific therapeutic procedure).in a French Comprehensive Cancer Center.

Exclusion criteria : None


Information from the National Library of Medicine

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


Contacts
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Contact: Mathieu Robain, MD, PhD + 33 1 44 23 55 52 m-robain@unicancer.fr
Contact: Coralie Courtinard, Msc +33 1 85 34 33 72 c-courtinard@unicancer.fr

Locations
Show Show 20 study locations
Sponsors and Collaborators
UNICANCER
Investigators
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Study Director: Mathieu Robain, MD, PhD UNICANCER
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Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT03275298    
Other Study ID Numbers: ESMEOVR
First Posted: September 7, 2017    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UNICANCER:
ovarian cancer
observational study
survival
real world data
real life setting
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type