- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03275298
Evolution of the Therapeutic Care in Ovarian Cancer From 2011 (ESME-OVR)
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
Study Overview
Status
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 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.
Hospitalisation 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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Angers, France, 49933
- Institut de Cancerologie de l'Ouest - Paul Papin
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Bordeaux, France, 33076
- Institut Bergonié
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Caen, France, 14076
- Centre François Baclesse
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Clermont-ferrand, France, 63011
- Centre Jean Perrin
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Dijon, France, 21079
- Centre Georges-Francois Leclerc
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Lille, France, 59020
- Centre Oscar Lambret
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Lyon, France, 69373
- Centre Leon Bérard
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Marseille, France, 13273
- Institut Paoli-Calmettes
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Montpellier, France, 34298
- Institut régional du Cancer Montpellier / Val d'Aurelle
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Nancy, France, 54511
- Institut de cancérologie de Lorraine
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Nantes, France, 44805
- Institut de cancérologie de l'Ouest - René Gauducheau
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Nice, France, 06189
- Centre Antoine Lacassagne
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Paris, France, 75005
- Institut Curie
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Reims, France, 51056
- Institut Jean Godinot
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Rennes, France, 35042
- Centre Eugène Marquis
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Rouen, France, 76038
- Centre Henri Becquerel
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Saint-Cloud, France, 92210
- Institut Curie - Hôpital René Huguenin
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Strasbourg, France, 67065
- Centre Paul Strauss
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Toulouse, France, 31059
- Institut Claudius Regaud
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Villejuif, France, 94805
- Institut Gustave Roussy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
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 |
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Describe the evolution of therapeutic care in ovarian cancer across the French comprehensive cancer centers
Time Frame: baseline
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Patient characteristics, tumor characteristics and treatment patterns
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baseline
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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 2022.
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Overall survival
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From date of diagnosis or first treatment until the date of date of death from any cause. Follow up until 2022.
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Other 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 first documented progression or date of death from any cause. Follow up until 2022.
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Progression free survival
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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.
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Romeo, C, P Meeus, M Rodrigues, E Leblanc, A Floquet, P Pautier, F Marchal, et al. " EP967 Natural history of patients with BRCA-mutated high grade epithelial ovarian cancer (HGEOC) before the era of PARP inhibitors maintenance in 1st line treatment ". In ePoster, A513.3-A513. BMJ Publishing Group Ltd, 2019. https://doi.org/10.1136/ijgc-2019-ESGO.1013.
- De Nonneville A, Zemmour C, Frank S, Joly F, Ray-Coquard I, Costaz H, Classe JM, Floquet A, De la Motte Rouge T, Colombo PE, Sauterey B, Leblanc E, Pomel C, Marchal F, Barranger E, Savoye AM, Guillemet C, Petit T, Pautier P, Rouzier R, Gladieff L, Simon G, Courtinard C, Sabatier R. Clinicopathological characterization of a real-world multicenter cohort of endometrioid ovarian carcinoma: Analysis of the French national ESME-Unicancer database. Gynecol Oncol. 2021 Oct;163(1):64-71. doi: 10.1016/j.ygyno.2021.07.019. Epub 2021 Jul 19.
- Rodrigues M, Joly F, Ray-Coquard I, Costaz H, Classe JM, Floquet A, De la Motte Rouge T, Colombo PE, Provensal Gross M, Leblac E, Pomel C, Marchal F, Barranger E, Savoye AM, Guillemet C, Petit T, Pautier P, Rouzier R, Courtinard C, Gladieff L. Real-world clinical outcomes of patients with de novo advanced high-grade epithelial ovarian cancer eligible to niraparib maintenance in France. ESMO Congress, September 16-21, 2021 [ePoster 746P] DOI:https://doi.org/10.1016/j.annonc.2021.08.1188
- Thomas QD, Boussere A, Classe JM, Pomel C, Costaz H, Rodrigues M, Ray-Coquard I, Gladieff L, Rouzier R, Rouge TM, Gouy S, Barranger E, Sabatier R, Floquet A, Marchal F, Guillemet C, Polivka V, Martin AL, Colombo PE, Fiteni F. Optimal timing of interval debulking surgery for advanced epithelial ovarian cancer: A retrospective study from the ESME national cohort. Gynecol Oncol. 2022 Oct;167(1):11-21. doi: 10.1016/j.ygyno.2022.08.005. Epub 2022 Aug 13.
- Bini M, Quesada S, Meeus P, Rodrigues M, Leblanc E, Floquet A, Pautier P, Marchal F, Provansal M, Campion L, Causeret S, Gourgou S, Ray-Coquard I, Classe JM, Pomel C, De La Motte Rouge T, Barranger E, Savoye AM, Guillemet C, Gladieff L, Demarchi M, Rouzier R, Courtinard C, Romeo C, Joly F. Real-World Data on Newly Diagnosed BRCA-Mutated High-Grade Epithelial Ovarian Cancers: The French National Multicenter ESME Database. Cancers (Basel). 2022 Aug 21;14(16):4040. doi: 10.3390/cancers14164040.
- Brouillard-Saby F, Saint-Martin C, Ray-Coquard I, Gladieff L, Pomel C, Colombo PE, Classe JM, Chevrier M, Joly F, De la Motte Rouge T, Floquet A, Sabatier R, Barranger E, Costaz H, Leblanc E, Marchal F, Pautier P, Bosquet L, Rodrigues M. Efficacy of chemotherapy according to BRCA status in patients with high-grade serous ovarian carcinoma at first platinum-sensitive relapse. Int J Gynecol Cancer. 2023 Apr 3;33(4):577-584. doi: 10.1136/ijgc-2022-003993.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- ESMEOVR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Ovarian Cancer
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Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
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City of Hope Medical CenterNational Cancer Institute (NCI)CompletedCancer Survivor | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIA Ovarian Epithelial Cancer | Stage IIB Ovarian Epithelial Cancer | Stage IIC Ovarian Epithelial Cancer | Stage IA Ovarian Epithelial Cancer | Stage IB Ovarian... and other conditionsUnited States
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Massachusetts General HospitalJohns Hopkins University; M.D. Anderson Cancer Center; National Cancer Institute... and other collaboratorsRecruitingOvarian Neoplasms | Fallopian Tube Neoplasms | Stage III Ovarian Cancer AJCC v8 | Stage IIIA Ovarian Cancer AJCC v8 | Stage IIIA1 Ovarian Cancer AJCC v8 | Stage IIIA2 Ovarian Cancer AJCC v8 | Stage IIIB Ovarian Cancer AJCC v8 | Stage IIIC Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Stage... and other conditionsUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Seromucinous Carcinoma | Ovarian Serous Cystadenocarcinoma | Stage IV Ovarian Germ Cell Tumor | Ovarian Sarcoma | Malignant Ovarian Epithelial Tumor | Ovarian Carcinosarcoma | Ovarian Brenner Tumor | Ovarian Mucinous... and other conditionsUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedStage IIA Fallopian Tube Cancer | Stage IIA Ovarian Cancer | Stage IIB Fallopian Tube Cancer | Stage IIB Ovarian Cancer | Stage IIC Fallopian Tube Cancer | Stage IIC Ovarian Cancer | Stage IIIA Fallopian Tube Cancer | Stage IIIA Ovarian Cancer | Stage IIIA Primary Peritoneal Cancer | Stage IIIB Fallopian... and other conditionsUnited States
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University of WashingtonNational Cancer Institute (NCI)CompletedCaregiver | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
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Eve RodlerNot yet recruitingBreast Cancer | Ovarian Cancer | Breast Neoplasm | Breast Carcinoma | Breast Cancer Stage IV | Breast Cancer Stage I | Breast Cancer Stage II | Invasive Breast Cancer | Cancer, Breast | Breast Cancer Stage III | Ovary Cancer | Malignant Tumor of Breast | Ovarian Cancer Stage IIIC | Ovarian Cancer Stage IV | Ovarian Cancer... and other conditionsUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)RecruitingStage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
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Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
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Centre Leon BerardCancer Côte d'or registry; Cancer Calvados registryUnknownOvarian Epithelial CancerFrance