Evaluating outcomes in advanced ovarian cancer based on genetic testing

Measure of Outcomes in Patients With Advanced Ovarian Cancer According to Homologous Recombination Status and Matched Therapies in a Real-world Scenario: A Retrospective and Prospective, Multicenter, Two Cohorts Study

This study is testing how well different treatments work for women with advanced ovarian cancer based on their genetic makeup.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Consorzio Oncotech (Academic / other)
• Drugs / interventions: Bevacizumab, chemotherapy
• Locations: 21 sites (Bari, BA and 20 other locations)
• Trial ID: NCT06836219 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the clinical outcomes and safety of patients with advanced high-grade ovarian cancer, focusing on their homologous recombination (HR) status. Patients will be divided into two cohorts: those with homologous recombination deficiency (HRD) treated with Olaparib and Bevacizumab after initial chemotherapy, and those with homologous recombination proficiency (HRP) receiving standard treatment. The study will include both retrospective and prospective enrollment of patients diagnosed between January 2021 and January 2026, utilizing validated HRD tests. The goal is to gather real-world data on treatment effectiveness based on genetic profiles.

Who should consider this trial

Good fit: Ideal candidates are females aged 18 and older diagnosed with high-grade serous or endometroid ovarian cancer who have undergone homologous recombination testing.

Not a fit: Patients with low-grade ovarian cancer or those who have not undergone homologous recombination testing may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with advanced ovarian cancer.

How similar studies have performed: Other studies have shown promising results in using homologous recombination status to guide treatment decisions in ovarian cancer, indicating a potential for success in this approach.

Eligibility criteria

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

Where this trial is running

Bari, BA and 20 other locations

• Istituto Tumori "Giovanni Paolo II" I.R.C.C.S. — Bari, Ba, Italy (Recruiting)
• Azienda Ospedaliero Universitaria di Bologna - Policlinico S.Orsola-Malpighi — Bologna, Bo, Italy (Recruiting)
• Azienda Ospedaliera S.Croce e Carle Cuneo — Cuneo, Cn, Italy (Recruiting)
• Azienda Ospedaliera per l'emergenza Cannizzaro — Catania, CT, Italy (Recruiting)
• IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" — Meldola, Fc, Italy (Recruiting)
• Azienda Ospedaliero Universitario Careggi — Florence, Fi, Italy (Recruiting)
• IRCCS Policlinico San Martino — Genova, Ge, Italy (Recruiting)
• Fondazione IRCCS San Gerardo dei Tintori (Monza) — Monza, Mb, Italy (Not_yet_recruiting)
• Università Vita-Salute San Raffaele (IRCCS San Raffaele - Milano) — Milan, Mi, Italy (Recruiting)
• Istituto Nazionale Tumori (INT) - Milano — Milan, Mi, Italy (Recruiting)
• Istituto Oncologico Veneto (IOV) — Padova, Pd, Italy (Recruiting)
• Ospedale S. Maria della Misericordia — Perugia, Pg, Italy (Recruiting)
• Centro di riferimento oncologico - CRO di Aviano — Aviano, Pn, Italy (Recruiting)
• Istituto Nazionale Tumori Regina Elena - Roma — Roma, Rm, Italy (Recruiting)
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Rm, Italy (Recruiting)
• Ospedale San Paolo - ASL2 - Savona — Savona, Sv, Italy (Recruiting)
• Ospedale Mauriziano Umberto I — Torino, To, Italy (Recruiting)
• Azienda sanitaria universitaria Friuli Centrale (ASU FC) — Udine, Ud, Italy (Recruiting)
• Azienda Ulss 3 Serenissima — Mestre, Ve, Italy (Recruiting)
• Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale — Naples, Italy (Recruiting)
• Università degli Studi di Napoli "Federico II" — Naples, Italy (Recruiting)

Study contacts

• Study coordinator: Michele B Michele Bartoletti, MD

Conditions Ovarian Cancer; Homologous Recombination status