About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Female, age ≥ 18 years at the time of diagnosis
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.
Disqualifiers
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
Trial population
All patients diagnosed with advanced high grade ovarian cancer who have received a homologous recombination analysis using validated HRD test between January 2021 and January 2026 are eligible. Patients resulted HRD and treated with Olaparib plus Bevacizumab will be included in Cohort A while patient with HRP tumors will be included in the Cohort B. Patients enrolled in the "compassionate use" of Olaparib (CNN program) can be included as well as patients who have received therapies according to clinical practice.
Trial design
Cohort
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Evaluate the clinical outcomes
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
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
Toxicity evaluated according to CTCAE vers 5.0
Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort
Percentage of patients with dose reductions
Secondary outcomes
Describe the clinical outcomes
according to disease stage
Describe the clinical outcomes
according to surgical timing
Describe the clinical outcomes
according to residual disease after surgery in each cohort
Describe the clinical characteristics of patients for which the combination therapy was offered (Cohort A)
Describe the clinical characteristics of patients for which the combination therapy was offered (Cohort A)
Sponsors and contacts
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