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Ovarian CancerESME OCNCT03275298

Evolution of the Therapeutic Care in Ovarian Cancer From 2011

An observational study of Ovarian Cancer, run by UNICANCER at 20 sites in France.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
How many people
13,331 participants
Where
20 sitesFrance
Study dates
1 Apr 2017to 31 Dec 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

None listed.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

France20 sites

  • Institut de Cancérologie de l'Ouest - Paul Papin

    Angers, 49933

  • Institut Bergonié

    Bordeaux, 33076

  • Centre François Baclesse

    Caen, 14076

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre Georges-François Leclerc

    Dijon, 21079

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Léon Bérard

    Lyon, 69373

  • Institut Paoli-Calmettes

    Marseille, 13273

  • Institut régional du Cancer Montpellier / Val d'Aurelle

    Montpellier, 34298

  • Institut de Cancérologie de Lorraine

    Nancy, 54511

  • Institut de cancérologie de l'Ouest - René Gauducheau

    Nantes, 44805

  • Centre Antoine Lacassagne

    Nice, 06189

  • Institut Curie

    Paris, 75005

  • Institut Jean Godinot

    Reims, 51056

  • Centre Eugène Marquis

    Rennes, 35042

  • Centre Henri Becquerel

    Rouen, 76038

  • Institut Curie - Hôpital René Huguenin

    Saint-Cloud, 92210

  • Centre Paul Strauss

    Strasbourg, 67065

  • Institut Claudius Regaud

    Toulouse, 31059

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official title: Epidemiological Strategy and Medical Economic (ESME) Research Program / Academic Real World Database : Evolution of the Therapeutic Care in Ovarian Cancer Across the French Comprehensive Cancer Centers From 2011

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).

Read the detailed description

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
Ovarian Cancer
Keywords
ovarian cancer, observational study, survival, real world data, real life setting
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03275298
Study groupRoleWhat they receive
Ovarian cancer cohortAny female treated for ovarian cancer in a French comprehensive cancer centers

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Patient characteristics, tumor characteristics and treatment patterns

    Measured: baseline

Secondary outcomes (1)

  1. Describe the impact of therapeutic strategies on survival criteria

    Overall survival

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2017
  2. Study start1 Apr 2017
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2026 (estimated)

Why it stopped: enrolment temporariliy stopped for budget considerations

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
13,331 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03275298
Sponsor's protocol ID
ESME OC
Acronym
ESME OC
Status last verified
Apr 2026
First submitted
27 Jun 2017
Last updated
27 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

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.

    PubMed 34294414

  • 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.

    PubMed 35970603

  • 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.

    PubMed 36011033

  • 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.

    PubMed 36631150

  • 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.

    PubMed 40349134

  • Chator C, Chevrier M, Frenel JS, Guyon F, Sabatier R, Pomel C, Rouge TM, Pautier P, Gladieff L, Follana P, Colombo PE, Petit T, Guillemet C, Marchal F, Narducci F, Fumet JD, Rodrigues M, Bosquet L, Rouzier R, Ray-Coquard I. Role of platinum-free interval (PFI) and maintenance therapies in recurrent ovarian cancer to explain survival. An analysis from the French real-world ESME Ovarian Database. Gynecol Oncol. 2025 Oct;201:17-25. doi: 10.1016/j.ygyno.2025.08.004. Epub 2025 Aug 7.

    PubMed 40779880

  • Papazyan T, Martin E, Pautier P, Guerin-Charbonnel C, Rowinski E, Lecuru F, Joly F, De La Motte Rouge T, Guillemet C, Costaz H, Sabatier R, Barranger E, Colombo PE, Marchal F, Pomel C, Savoye AM, Bosquet L, Ray-Coquard I, Gladieff L, Loaec C, Frenel JS. Surgical approach and maintenance therapy in advanced low-grade serous ovarian cancer: Insights from the French ESME database. Int J Gynecol Cancer. 2026 Feb;36(2):102804. doi: 10.1016/j.ijgc.2025.102804. Epub 2025 Nov 14.

    PubMed 41411701

  • Mokarram Dorri N, Foulhioux L, Zemmour C, Thomas QD, Costaz H, Narducci F, Petit T, Loaec C, Laas E, Gyuon F, Cherifi F, Savoye AM, Ferraioli D, Rossi L, De la Motte Rouge T, Marchal F, Gosset M, Pomel C, Martin AL, Lambaudie E. Metastatic sites and surgical management in stage IV ovarian cancer: Is there a place for debulking surgery in FIGO stage IVB patients? A retrospective study from the ESME national cohort. Clin Surg Oncol. 2025; 4(4)

  • Le Bars S, Guerin-Charbonnel C, Martin E, Thomas QD, Costaz H, Pomel C, Marchal F, Narducci F, Gouy S, Laas E, Rossi L, Lambaudie E, Rouzier R, Petit T, Gladieff L, De La Motte Rouge T, Bosquet L, Colombo PE, Classe JM, Loaec C. Advanced high-grade serous ovarian cancer treated with intensive cytoreductive surgery and chemotherapy: prognostic impact of lymph node involvement: analysis of the French national ESME-Unicancer database. Eur J Surg Oncol. 2026 Jun;52(6):111768. doi: 10.1016/j.ejso.2026.111768. Epub 2026 Mar 25.

    PubMed 42013623

  • Becker O, Durand A, Chevrier M, Collet L, Gladieff L, Joly F, Sauterey B, Pomel C, Costaz H, Pautier P, Guillemet C, Rouge TM, Sabatier R, Classe JM, Petit T, Leblanc E, Marchal F, Colombo PE, Barranger E, Savoye AM, Bosquet L, Ray-Coquard I, Carton M, Colomban O, You B, Rodrigues M. Tumor-intrinsic chemosensitivity assessed by KELIM and prognosis by BRCA status in patients with advanced ovarian carcinomas. Int J Gynecol Cancer. 2025 May;35(5):101866. doi: 10.1136/ijgc-2024-005815. Epub 2025 Apr 19.

    PubMed 39481880

Questions about this trial

What is this clinical trial studying?

An observational study of Ovarian Cancer, run by UNICANCER at 20 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Describe the evolution of therapeutic care in ovarian cancer across the French comprehensive cancer centers (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03275298, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.

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