Clinical Trials in Italy / NCT06836219
Recruiting
Observational
Measure of Outcomes in Patients With Advanced Ovarian Cancer According to Homologous Recombination Status and Matched Therapies in a Real-world Scenario
NCT06836219 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Ovarian Cancer
Study summary
This is a retrospective and prospective, multicenter, observational, two-cohorts study aimed to evaluate clinical outcomes and safety of patients diagnosed with advanced high grade ovarian cancer whose tumor was tested for the homologous recombination (HR) status using a validated HR deficiency test between January 2021 and January 2026.
* Cohort A: Homologous Recombination Deficient (HRD) ovarian cancer patients treated with Olaparib plus Bevacizumab as maintenance therapies after partial or complete response to first line platinum-based chemotherapy.
* Cohort B: Homologous Recombination Proficient (HRP) ovarian cancer patients treated as for standard clinical practice at clinician's choice.
Eligibility
Inclusion Criteria:
* Female, age ≥ 18 years at the time of diagnosis
* Patients diagnosed with high-grade serous or endometroid ovarian, fallopian tube, or primary peritoneal cancer undergone to Homologous Recombination test with the MyChoice HRD assay, FoundationOne DX assay or another validated HRD test, between January 2021 and January 2026:
* Patients with HRD score \> 42 or Loss of Heterozygosity (LOH) score high or defined as HR deficient with other tests and treated with Bevacizumab and Olaparib after first line platinumbased chemotherapy will be retrospectively or prospectively enrolled in Cohort A
* Patients with HRD score \< 42 or Loss of Heterozygosity (LOH) score low or defined as HR proficient with other tests and treated with first line platinum-based chemotherapy with or without bevacizumab or others targeted agents will be retrospectively or prospectively enrolled in Cohort B
* Patients must be able to understand the study procedures and agree to participate in the study by providing written informed consent.
Exclusion Criteria:
* Patients who have not performed a validated Homologous Recombination test on tumor sample.
* Patients with germline or somatic BRCA 1 or 2 mutations
* Patients death at the time of inclusion in the current study
Primary outcome measure(s)
- Evaluate the clinical outcomes — Until 3 years from enrollment
The clinical outcomes that will be measured in both study cohorts are: progression-free survival (PSF) as the time from treatment's start to disease progression or death for any cause - Evaluate the clinical outcomes — Until 3 years from enrollment
The clinical outcomes that will be measured in both study cohorts are: overall survival (OS) as the time from treatment's start to death for any cause - Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort — Until 3 years from enrollment
Toxicity evaluated according to CTCAE vers 5.0 - Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort — Until 3 years from enrollment
Percentage of patients with dose reductions - Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort — Until 3 years from enrollment
Percentage of patients with dose interruptions due to toxicity - Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort — Until 3 years from enrollment
Percentage of patients with treatment discontinuations due to toxicity - Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort — Until 3 years from enrollment
Toxicity according to initial dose of targeted agents - Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort — Until 3 years from enrollment
Incidence of myelodysplastic syndrome and acute myeloid leukaemia in patients receiving PARPi
Trial sites (21)
| Facility | City | Region | Status |
|---|---|---|---|
| Istituto Tumori "Giovanni Paolo II" I.R.C.C.S. | Bari | BA | Recruiting |
| Azienda Ospedaliero Universitaria di Bologna - Policlinico S.Orsola-Malpighi | Bologna | BO | Recruiting |
| Azienda Ospedaliera S.Croce e Carle Cuneo | Cuneo | CN | Recruiting |
| Azienda Ospedaliera per l'emergenza Cannizzaro | Catania | CT | Recruiting |
| IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" | Meldola | FC | Recruiting |
| Azienda Ospedaliero Universitario Careggi | Florence | FI | Recruiting |
| IRCCS Policlinico San Martino | Genova | GE | Recruiting |
| Fondazione IRCCS San Gerardo dei Tintori (Monza) | Monza | MB | Not Yet Recruiting |
| Università Vita-Salute San Raffaele (IRCCS San Raffaele - Milano) | Milan | MI | Recruiting |
| Istituto Nazionale Tumori (INT) - Milano | Milan | MI | Recruiting |
| Istituto Oncologico Veneto (IOV) | Padova | PD | Recruiting |
| Ospedale S. Maria della Misericordia | Perugia | PG | Recruiting |
| Centro di riferimento oncologico - CRO di Aviano | Aviano | PN | Recruiting |
| Istituto Nazionale Tumori Regina Elena - Roma | Roma | RM | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma | RM | Recruiting |
| Ospedale San Paolo - ASL2 - Savona | Savona | SV | Recruiting |
| Ospedale Mauriziano Umberto I | Torino | TO | Recruiting |
| Azienda sanitaria universitaria Friuli Centrale (ASU FC) | Udine | UD | Recruiting |
| Azienda Ulss 3 Serenissima | Mestre | VE | Recruiting |
| Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale | Naples | Italy | Recruiting |
| Università degli Studi di Napoli "Federico II" | Naples | Italy | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06836219 on ClinicalTrials.gov ↗ ← All trials in Italy