Measure of Outcomes in Patients With Advanced Ovarian Cancer According to Homologous Recombination Status and Matched Therapies in a Real-world Scenario

Recruiting now

Conditions studied: Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT06836219

Run by

Consorzio Oncotech

People needed

300

Starts

2024-09-13

Expected to finish

2029-01-01

Last updated by the study team

2025-02-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Università degli Studi di Napoli "Federico II" — Naples, Italy (enrolling)
• Azienda Ospedaliero Universitaria di Bologna - Policlinico S.Orsola-Malpighi — Bologna, BO, Italy (enrolling)
• Azienda Ospedaliera S.Croce e Carle Cuneo — Cuneo, CN, Italy (enrolling)
• Azienda Ospedaliera per l'emergenza Cannizzaro — Catania, CT, Italy (enrolling)
• IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" — Meldola, FC, Italy (enrolling)
• Azienda Ospedaliero Universitario Careggi — Florence, FI, Italy (enrolling)
• IRCCS Policlinico San Martino — Genova, GE, Italy (enrolling)
• Istituto Tumori "Giovanni Paolo II" I.R.C.C.S. — Bari, BA, Italy (enrolling)
• Università Vita-Salute San Raffaele (IRCCS San Raffaele - Milano) — Milan, MI, Italy (enrolling)
• Istituto Nazionale Tumori (INT) - Milano — Milan, MI, Italy (enrolling)
• Istituto Oncologico Veneto (IOV) — Padova, PD, Italy (enrolling)
• Ospedale S. Maria della Misericordia — Perugia, PG, Italy (enrolling)
• Centro di riferimento oncologico - CRO di Aviano — Aviano, PN, Italy (enrolling)
• Istituto Nazionale Tumori Regina Elena - Roma — Roma, RM, Italy (enrolling)
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, RM, Italy (enrolling)
• Ospedale San Paolo - ASL2 - Savona — Savona, SV, Italy (enrolling)
• Ospedale Mauriziano Umberto I — Torino, TO, Italy (enrolling)
• Azienda sanitaria universitaria Friuli Centrale (ASU FC) — Udine, UD, Italy (enrolling)
• Azienda Ulss 3 Serenissima — Mestre, VE, Italy (enrolling)
• Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale — Naples, Italy (enrolling)
• Fondazione IRCCS San Gerardo dei Tintori (Monza) — Monza, MB, Italy

Full record on ClinicalTrials.gov

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