Clinical trial NCT03275298: Evolution of the Therapeutic Care in Ovarian Cancer From 2011
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
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Ovarian Cancer
Keywords: ovarian cancer
observational study
survival
real world data
real life setting
Lead sponsor: UNICANCER
Sponsor class: OTHER
First posted: 2017-09-07
Enrollment: 13331
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive females treated for an ovarian cancer in a French Comprehensive Cancer Center over the selection period.

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).

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.

Eligibility criteria: 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.

Exclusion criteria : None

Primary outcomes:
measure: Describe the evolution of therapeutic care in ovarian cancer across the French comprehensive cancer centers
timeFrame: baseline
Secondary outcomes:
measure: Describe the impact of therapeutic strategies on survival criteria
timeFrame: From date of diagnosis or first treatment until the date of date of death from any cause. Follow up until 2022.
Other outcomes:
measure: Describe the impact of therapeutic strategies on survival criteria
timeFrame: 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.
Locations:
city: Angers
country: France
facility: Institut de Cancérologie de l'Ouest - Paul Papin
city: Bordeaux
country: France
facility: Institut Bergonié
city: Caen
country: France
facility: Centre François Baclesse
city: Clermont-ferrand
country: France
facility: Centre Jean Perrin
city: Dijon
country: France
facility: Centre Georges-François Leclerc
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Montpellier
country: France
facility: Institut régional du Cancer Montpellier / Val d'Aurelle
city: Nancy
country: France
facility: Institut de Cancérologie de Lorraine
city: Nantes
country: France
facility: Institut de cancérologie de l'Ouest - René Gauducheau
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Institut Curie
city: Reims
country: France
facility: Institut Jean Godinot
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint-Cloud
country: France
facility: Institut Curie - Hôpital René Huguenin
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
References:
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: 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.