Clinical trial NCT06660147: Validation of KELIM as a Predictive/Prognostic Factor for Maintenance Treatment With iPARP in First-Line Ovarian Cancer
Official title: PAOLA-1 Ancillary Study: Retrospective Validation of KELIM as a Predictive and Prognostic Factor for Maintenance Treatment With PARP Inhibitor After Platinum-Based Chemotherapy in First-Line Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Cancer
Keywords: parp inhibitor
kelim
maintenance treatment
Lead sponsor: ARCAGY/ GINECO GROUP
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 327
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: Patients randomised in the PAOLA-1 study :

Patients with advanced FIGO stage IIIB-IV high grade serous or endometrioid ovarian, fallopian tube, or peritoneal cancer treated with standard first line treatment combining platinum based chemotherapy plus bevacizumab followed by a maintenance treatment by bevacizumab and Olaparib or placebo.

Brief summary: This study aims to understand whether it is possible to predict the effectiveness of maintenance treatment with PARP inhibitors following first-line chemotherapy in ovarian cancer, and thus better target the patients who benefit from this treatment


Eligibility criteria: Inclusion Criteria: Patients randomised in the PAOLA-1 study -

Exclusion Criteria:Opposition to the use of your data for research purposes.

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Primary outcomes:
measure: predictive and prognostic value of the KELIM score
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: ICO Paul Papin
city: Avignon
country: France
facility: Sainte-Catherine Institut du Cancer Avignon-Provence
city: Besançon
country: France
facility: CHRU Besançon - Hôpital Jean Minjoz
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord
city: Caen
country: France
facility: Centre François Baclesse
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Grenoble
country: France
facility: CHU Grenoble-Alpes - Site Nord (La Tronche)
city: La Roche-sur-Yon
country: France
facility: Centre Hospitalier Départemental de Vendée
city: Mougins
country: France
facility: Centre Azuréen de Cancérologie
city: Nantes
country: France
facility: Hôpital Privé du Confluent
city: Paris
country: France
facility: Groupe Hospitalier Diaconesses - Croix Saint-Simon
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: Institut Curie
city: Pierre-Bénite
country: France
facility: HCL - Centre Hospitalier Lyon Sud
city: Poitiers
country: France
facility: CHU de Poitiers - Hôpital de la Milétrie
city: Périgueux
country: France
facility: Clinique Francheville
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Saint-Herblain
country: France
facility: ICO - Centre René Gauducheau
city: Toulouse
country: France
facility: Oncopole Claudius Regaud - IUCT Oncopole
city: Toulouse
country: France
facility: Clinique Pasteur
city: Vandœuvre-lès-Nancy
country: France
facility: ICL - Centre Alexis Vautrin
city: Villejuif
country: France
facility: Gustave Roussy
city: Monaco
country: Monaco
facility: Centre Hospitalier Princesse Grace
Study officials:
References: