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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorConsorzio Oncotech

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 2 trial groups
Group A: Cohort A: Homologous Recombination Deficient (HRD)
Group B: Cohort B: Homologous Recombination Proficient (HRP)

Trial outcomes

Primary outcomes

1

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

Time frame
Until 3 years from enrollment
2

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

Time frame
Until 3 years from enrollment
3

Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort

Toxicity evaluated according to CTCAE vers 5.0

Time frame
Until 3 years from enrollment
4

Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort

Percentage of patients with dose reductions

Time frame
Until 3 years from enrollment

Secondary outcomes

1

Describe the clinical outcomes

according to disease stage

Time frame
Until 3 years from enrollment
2

Describe the clinical outcomes

according to surgical timing

Time frame
Until 3 years from enrollment
3

Describe the clinical outcomes

according to residual disease after surgery in each cohort

Time frame
Until 3 years from enrollment
4

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)

Time frame
Until 3 years from enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.