NCT03275298

Brief Summary

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).

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
13,331

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Longer than P75 for all trials

Geographic Reach
1 country

20 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 7, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 23, 2025

Status Verified

March 1, 2025

Enrollment Period

2.8 years

First QC Date

June 27, 2017

Last Update Submit

April 22, 2025

Conditions

Keywords

ovarian cancerobservational studysurvivalreal world datareal life setting

Outcome Measures

Primary Outcomes (1)

  • Describe the evolution of therapeutic care in ovarian cancer across the French comprehensive cancer centers

    Patient characteristics, tumor characteristics and treatment patterns

    baseline

Secondary Outcomes (1)

  • Describe the impact of therapeutic strategies on survival criteria

    From date of diagnosis or first treatment until the date of date of death from any cause. Follow up until 2022.

Other Outcomes (1)

  • Describe the impact of therapeutic strategies on survival criteria

    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.

Study Arms (1)

Ovarian cancer cohort

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive females treated for an ovarian cancer in a French Comprehensive Cancer Center over the selection period.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Institut de Cancérologie de l'Ouest - Paul Papin

Angers, 49933, France

Location

Institut Bergonié

Bordeaux, 33076, France

Location

Centre François Baclesse

Caen, 14076, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Centre Georges-François Leclerc

Dijon, 21079, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

Institut Paoli-Calmettes

Marseille, 13273, France

Location

Institut régional du Cancer Montpellier / Val d'Aurelle

Montpellier, 34298, France

Location

Institut de Cancérologie de Lorraine

Nancy, 54511, France

Location

Institut de cancérologie de l'Ouest - René Gauducheau

Nantes, 44805, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Institut Curie

Paris, 75005, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Centre Eugène Marquis

Rennes, 35042, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Institut Curie - Hôpital René Huguenin

Saint-Cloud, 92210, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

Institut Claudius Regaud

Toulouse, 31059, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Related Publications (7)

  • 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.

    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.

  • 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

    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.

  • 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.

  • 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.

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2017

First Posted

September 7, 2017

Study Start

April 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2025

Last Updated

April 23, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

In accordance with ethical and legal requirements related to the ESME Data Warehouse, individual data from the ESME databases cannot be made available outside Unicancer secured servers.

Locations