Clinical trial NCT04152941: Real-life Data of Olaparib in Relapsed Ovarian Cancers Patients
Official title: Observational Retrospective Cohort Study in Patients With Relapsed Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Treated With Olaparib Following Response to Platinium-based Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsed Ovarian Cancers Patients
Lead sponsor: ARCAGY/ GINECO GROUP
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2019-11-06
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient population observed in this study must fulfil all of the following inclusion criteria:

* Patients must be female ≥18 years of age
* Patients with histologically confirmed ovarian cancer, primary peritoneal cancer and / or fallopian-tube cancer that were treated with olaparib in a real life-setting, between May 2014 to March 2017, whatever the line of therapy
* Patients can be either alive or deceased at the time of medical record abstraction
* Patients should not have any objection that anonymized data will be collected and subjected to automated processing.

Brief summary: This is a national, multi center, retrospective observational cohort study that will be carried out by reviewing the medical records of patients with relapsed epithelial ovarian, fallopian tube, or peritoneal cancer treated with olaparib following response to platinum-based chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Patients must be female ≥18 years of age
* Patients with histologically confirmed ovarian cancer, primary peritoneal cancer and / or fallopian-tube cancer that were treated with olaparib in a real life-setting, between May 2014 to March 2017, whatever the line of therapy
* Patients can be either alive or deceased at the time of medical record abstraction
* Patients should not have any objection that anonymized data will be collected and subjected to automated processing.

Exclusion Criteria:

* Patient that were given olaparib within a clinical trial

Primary outcomes:
measure: progression free survival (PFS)
timeFrame: through study completion, an average of 1 year
measure: overall Survival (OS)
timeFrame: through study completion, an average of 1 year
measure: incidence of events of clinical interest
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: ICO Paul Papin
city: Avignon
country: France
facility: Institut Sainte-Catherine
city: Besancon
country: France
facility: CHRU Jean Minjoz
city: Bordeaux
country: France
facility: Clinique Tivoli
city: Bordeaux
country: France
facility: Institut Bergonié
city: Brest
country: France
facility: Clinique Pasteur
city: Brest
country: France
facility: Hôpital Morvan - Centre Hospitalier Universitaire
city: Clermont-ferrand
country: France
facility: Centre Jean Perrin
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Grenoble
country: France
facility: Groupe Hospitalier Mutualiste de Grenoble
city: Levallois Perret
country: France
facility: Institut Hospitalier Franco-Britannique
city: Lyon
country: France
facility: Centre Léon Bérard
city: Montpellier
country: France
facility: ICM Val d'Aurelle
city: Nancy
country: France
facility: ORACLE - Centre d'Oncologie de Gentilly
city: Nantes
country: France
facility: Hôpital Privé du Confluent S.A.S.
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Orleans
country: France
facility: Centre Hospitalier Régional d'Orléans
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Paris
country: France
facility: Hôpital Cochin
city: Reims
country: France
facility: Institut du Cancer Courlancy Reims
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Saint-brieuc
country: France
facility: Centre Hospitalier de Saint-Brieuc
city: Saint-herblain
country: France
facility: ICO Centre René Gauducheau
city: Saint-nazaire
country: France
facility: Clinique Mutualiste de l'Estuaire, Cité Sanitaire
city: Saint-priest-en-jarez
country: France
facility: Institut de Cancérologie Lucien Neuwirth
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
city: Vandœuvre-lès-Nancy
country: France
facility: ICL Institut de Cancérologie de Lorraine
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
affiliation: Centre Eugène Marquis
name: Thibault de La Motte Rouge, Dr
role: PRINCIPAL_INVESTIGATOR
References: