Evolution of the Therapeutic Care in Ovarian Cancer From 2011

NCT ID: NCT03275298

Last Updated: 2025-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

13331 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-01

Study Completion Date

2025-12-31

Brief Summary

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The ESME Ovarian Cancer database 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 existing data available from patient's electronic medical records (EMR).

Detailed Description

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This database compiles data from existing data available from patient's electronic medical records (EMR) and integrates data from non-structured ans structured sources.

The database includes data related to patient demographics, tumor characteristics (diagnosis, histology, relapses, metastatic disease, etc.), treatments (dates, INN, route of administration, treatment protocols, reason for termination, etc.), and clinical events. Data is collected at each participating site by technicians who are specifically trained for the project using an electronic data collection (eDC) tool.

Data imported into the final database are controlled, recoded, and harmonized before import according to the 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 is 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 OC database aims to be a clinical and therapeutic database centralizing existing and available data from different sources used in the participating hospitals. Data do not contain any personal data on patients. In compliance with the authorization delivered by the French Data Protection agency to Unicancer, only aggregated statistical reports and publication are released.

Conditions

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Ovarian Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Ovarian cancer cohort

Any female treated for ovarian cancer in a French comprehensive cancer centers

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 18 years old female
* Female who received surgery, chemotherapy, targeted therapy, immunotherapy, radiation therapy, diagnostic procedure, other specific therapeutic procedure) for ovarian cancer in a French Comprehensive Cancer Center.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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UNICANCER

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut de Cancérologie de l'Ouest - Paul Papin

Angers, , France

Site Status

Institut Bergonié

Bordeaux, , France

Site Status

Centre François Baclesse

Caen, , France

Site Status

Centre Jean Perrin

Clermont-Ferrand, , France

Site Status

Centre Georges-François Leclerc

Dijon, , France

Site Status

Centre Oscar Lambret

Lille, , France

Site Status

Centre Léon Bérard

Lyon, , France

Site Status

Institut Paoli-Calmettes

Marseille, , France

Site Status

Institut régional du Cancer Montpellier / Val d'Aurelle

Montpellier, , France

Site Status

Institut de Cancérologie de Lorraine

Nancy, , France

Site Status

Institut de cancérologie de l'Ouest - René Gauducheau

Nantes, , France

Site Status

Centre Antoine Lacassagne

Nice, , France

Site Status

Institut Curie

Paris, , France

Site Status

Institut Jean Godinot

Reims, , France

Site Status

Centre Eugène Marquis

Rennes, , France

Site Status

Centre Henri Becquerel

Rouen, , France

Site Status

Institut Curie - Hôpital René Huguenin

Saint-Cloud, , France

Site Status

Centre Paul Strauss

Strasbourg, , France

Site Status

Institut Claudius Regaud

Toulouse, , France

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT

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.

Reference Type RESULT
PMID: 34294414 (View on PubMed)

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

Reference Type RESULT

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.

Reference Type RESULT
PMID: 35970603 (View on PubMed)

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.

Reference Type RESULT
PMID: 36011033 (View on PubMed)

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.

Reference Type RESULT
PMID: 36631150 (View on PubMed)

Rippstein N, Zemmour C, Rodrigues M, Ray-Coquard I, Gladieff L, Pautier P, Frenel JS, Costaz H, Lebreton C, Pomel C, Colombo PE, Marchal F, Guillemet C, de la Motte Rouge T, Eberst L, Bosquet L, Deluche E, Sabatier R. PARP inhibitors as maintenance therapy in ovarian cancer after platinum-sensitive recurrence: real-world experience from the Unicancer network. Oncologist. 2025 May 8;30(5):oyaf075. doi: 10.1093/oncolo/oyaf075.

Reference Type DERIVED
PMID: 40349134 (View on PubMed)

Other Identifiers

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ESME OC

Identifier Type: -

Identifier Source: org_study_id

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