Evaluating outcomes in advanced ovarian cancer based on genetic testing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Michele B Michele Bartoletti, MD
• Email: michele.bartoletti@cro.it
• Phone: +39 334 500 7736

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.