NCT06660147

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

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
243

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2023

Geographic Reach
2 countries

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 11, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 28, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2025

Completed
Last Updated

June 23, 2026

Status Verified

June 1, 2026

Enrollment Period

1.1 years

First QC Date

October 14, 2024

Last Update Submit

June 19, 2026

Conditions

Keywords

parp inhibitorkelimmaintenance treatment

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

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

ICO Paul Papin

Angers, 49055, France

Location

Sainte-Catherine Institut du Cancer Avignon-Provence

Avignon, 84918, France

Location

CHRU Besançon - Hôpital Jean Minjoz

Besançon, 25030, France

Location

Polyclinique Bordeaux Nord

Bordeaux, 33300, France

Location

Centre François Baclesse

Caen, 14076, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

CHU Grenoble-Alpes - Site Nord (La Tronche)

Grenoble, 38043, France

Location

Centre Hospitalier Départemental de Vendée

La Roche-sur-Yon, 85925, France

Location

Centre Azuréen de Cancérologie

Mougins, 06250, France

Location

Hôpital Privé du Confluent

Nantes, France

Location

Groupe Hospitalier Diaconesses - Croix Saint-Simon

Paris, 75012, France

Location

Hôpital Cochin

Paris, 75014, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Institut Curie

Paris, 75248, France

Location

Clinique Francheville

Périgueux, 24004, France

Location

HCL - Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

CHU de Poitiers - Hôpital de la Milétrie

Poitiers, 86021, France

Location

Centre Eugène Marquis

Rennes, 35042, France

Location

ICO - Centre René Gauducheau

Saint-Herblain, 44805, France

Location

Oncopole Claudius Regaud - IUCT Oncopole

Toulouse, 31059, France

Location

Clinique Pasteur

Toulouse, 31300, France

Location

ICL - Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54519, France

Location

Gustave Roussy

Villejuif, 94805, France

Location

Centre Hospitalier Princesse Grace

Monaco, 98012, Monaco

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

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

January 21, 2025

Study Completion

January 21, 2025

Last Updated

June 23, 2026

Record last verified: 2026-06

Locations