Ovarian CancerKELI-PAOLANCT06660147
Validation of KELIM as a Predictive/Prognostic Factor for Maintenance Treatment With iPARP in First-Line Ovarian Cancer
An observational study of Ovarian Cancer, run by ARCAGY/ GINECO GROUP at 24 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- How many people
- 243 participants
- Where
- 24 sitesin 2 countries
- Study dates
- 11 Dec 2023to 21 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Inclusion Criteria: Patients randomised in the PAOLA-1 study -
Exclusion Criteria:Opposition to the use of your data for research purposes.
-
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
France23 sites
ICO Paul Papin
Angers, 49055
Sainte-Catherine Institut du Cancer Avignon-Provence
Avignon, 84918
CHRU Besançon - Hôpital Jean Minjoz
Besançon, 25030
Polyclinique Bordeaux Nord
Bordeaux, 33300
Centre François Baclesse
Caen, 14076
Centre Jean Perrin
Clermont-Ferrand, 63011
CHU Grenoble-Alpes - Site Nord (La Tronche)
Grenoble, 38043
Centre Hospitalier Départemental de Vendée
La Roche-sur-Yon, 85925
Centre Azuréen de Cancérologie
Mougins, 06250
Hôpital Privé du Confluent
Nantes
Groupe Hospitalier Diaconesses - Croix Saint-Simon
Paris, 75012
Hôpital Cochin
Paris, 75014
Hôpital Européen Georges Pompidou
Paris, 75015
Institut Curie
Paris, 75248
Clinique Francheville
Périgueux, 24004
HCL - Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
CHU de Poitiers - Hôpital de la Milétrie
Poitiers, 86021
Centre Eugène Marquis
Rennes, 35042
ICO - Centre René Gauducheau
Saint-Herblain, 44805
Oncopole Claudius Regaud - IUCT Oncopole
Toulouse, 31059
Clinique Pasteur
Toulouse, 31300
ICL - Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54519
Gustave Roussy
Villejuif, 94805
About this study
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
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
- Conditions
- Ovarian Cancer
- Keywords
- parp inhibitor, kelim, maintenance treatment
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start11 Dec 2023
- Primary completion21 Jan 2025
- Study completion21 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCAGY/ GINECO GROUP
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660147
- Sponsor's protocol ID
- GINECO OV131
- Acronym
- KELI-PAOLA
- Status last verified
- Jun 2026
- First submitted
- 14 Oct 2024
- Last updated
- 23 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06660147
- Acronym / sponsor ID
- KELI-PAOLA / GINECO OV131
- Conditions
- Ovarian Cancer
- Keywords
- parp inhibitor, kelim, maintenance treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- ARCAGY/ GINECO GROUPUniversity, hospital or other
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 21 Jan 2025 (actual)
- Study completion
- 21 Jan 2025 (actual)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
predictive and prognostic value of the KELIM score
Time frame: 18 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by ARCAGY/ GINECO GROUP at 24 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in France, Monaco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
predictive and prognostic value of the KELIM score (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.