Ovarian Cancer
Conditions
Keywords
Ovarian Cancer, Homologous Recombination status
Brief summary
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.
Detailed description
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 status using a validated HRD 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. Alive patients who have finished the first line treatment (including maintenance) with or without disease progression while signing the informed consent form will be enrolled retrospectively. Alive patients candidate to receive a first line therapy will be enrolledprospectively as soon as molecular data (BRCA status and HRD) are available.
Interventions
None listed
Sponsors
Consorzio Oncotech
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the clinical outcomes | Until 3 years from enrollment | 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 safety in patients treated with targeted anticancer therapies in each study cohort | Until 3 years from enrollment | Toxicity evaluated according to CTCAE vers 5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Describe the clinical outcomes | Until 3 years from enrollment | according to disease stage |
| Describe the clinical characteristics of patients for which the combination therapy was offered (Cohort A) | Until 3 years from enrollment | Describe the clinical characteristics of patients for which the combination therapy was offered (Cohort A) |
| Describe the treatment approach to HRP patients in a real word scenario in Italy (Cohort B) | Until 3 years from enrollment | Describe the treatment approach to HRP patients in a real word scenario in Italy (Cohort B) |
Countries
Italy
Contacts
Primary ContactMichele B Michele Bartoletti, MD
Backup ContactBeLIVE S BeLIVE Service
Outcome results
None listed