Validation of KELIM as a Predictive/Prognostic Factor for Maintenance Treatment With iPARP in First-Line Ovarian Cancer
KELI-PAOLA
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
1 other identifier
observational
327
2 countries
24
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2023
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 11, 2023
CompletedFirst Submitted
Initial submission to the registry
October 14, 2024
CompletedFirst Posted
Study publicly available on registry
October 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedOctober 28, 2024
October 1, 2024
1.1 years
October 14, 2024
October 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
predictive and prognostic value of the KELIM score
To evaluate the predictive and prognostic value of the KELIM score in patients receiving maintenance treatment with a PARP inhibitor as part of the PAOLA-1 clinical trial.
18 months
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
ICO Paul Papin
Angers, 49055, France
Sainte-Catherine Institut du Cancer Avignon-Provence
Avignon, 84918, France
CHRU Besançon - Hôpital Jean Minjoz
Besançon, 25030, France
Polyclinique Bordeaux Nord
Bordeaux, 33300, France
Centre François Baclesse
Caen, 14076, France
Centre Jean Perrin
Clermont-Ferrand, 63011, France
CHU Grenoble-Alpes - Site Nord (La Tronche)
Grenoble, 38043, France
Centre Hospitalier Départemental de Vendée
La Roche-sur-Yon, 85925, France
Centre Azuréen de Cancérologie
Mougins, 06250, France
Hôpital Privé du Confluent
Nantes, France
Groupe Hospitalier Diaconesses - Croix Saint-Simon
Paris, 75012, France
Hôpital Cochin
Paris, 75014, France
Hôpital Européen Georges Pompidou
Paris, 75015, France
Institut Curie
Paris, 75248, France
Clinique Francheville
Périgueux, 24004, France
HCL - Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
CHU de Poitiers - Hôpital de la Milétrie
Poitiers, 86021, France
Centre Eugène Marquis
Rennes, 35042, France
ICO - Centre René Gauducheau
Saint-Herblain, 44805, France
Oncopole Claudius Regaud - IUCT Oncopole
Toulouse, 31059, France
Clinique Pasteur
Toulouse, 31300, France
ICL - Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54519, France
Gustave Roussy
Villejuif, 94805, France
Centre Hospitalier Princesse Grace
Monaco, 98012, Monaco
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2024
First Posted
October 28, 2024
Study Start
December 11, 2023
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
October 28, 2024
Record last verified: 2024-10