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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Homologous Recombination Deficient (HRD) | 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) | Homologous Recombination Proficient (HRP) ovarian cancer patients treated as for standard clinical practice at clinician's choice. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Until 3 years from enrollment |
| 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 | Until 3 years from enrollment |
| Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort | Toxicity evaluated according to CTCAE vers 5.0 | Until 3 years from enrollment |
| Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort | Percentage of patients with dose reductions | Until 3 years from enrollment |
| Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort | Percentage of patients with dose interruptions due to toxicity | Until 3 years from enrollment |
| Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort | Percentage of patients with treatment discontinuations due to toxicity | Until 3 years from enrollment |
| Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort |
| Measure | Description | Time Frame |
|---|---|---|
| Describe the clinical outcomes | according to disease stage | Until 3 years from enrollment |
| Describe the clinical outcomes | according to surgical timing |
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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 must be able to understand the study procedures and agree to participate in the study by providing written informed consent.
Exclusion Criteria:
Female
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michele B Michele Bartoletti, MD | Contact | +39 334 500 7736 | 334 500 7736 | michele.bartoletti@cro.it |
| BeLIVE S BeLIVE Service | Contact | belive@cr-technology.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Tumori "Giovanni Paolo II" I.R.C.C.S. | Recruiting | Bari | BA | 70124 | Italy |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 8, 2024 | Feb 7, 2025 |
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Toxicity according to initial dose of targeted agents |
| Until 3 years from enrollment |
| Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort | Incidence of myelodysplastic syndrome and acute myeloid leukaemia in patients receiving PARPi | Until 3 years from enrollment |
| Until 3 years from enrollment |
| Describe the clinical outcomes | according to residual disease after surgery in each cohort | Until 3 years from enrollment |
| 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) | Until 3 years from enrollment |
| Describe the treatment approach to HRP patients in a real word scenario in Italy (Cohort B) | Describe the treatment approach to HRP patients in a real word scenario in Italy (Cohort B) | Until 3 years from enrollment |
| Azienda Ospedaliero Universitaria di Bologna - Policlinico S.Orsola-Malpighi | Recruiting | Bologna | BO | 40138 | Italy |
|
| Azienda Ospedaliera S.Croce e Carle Cuneo | Recruiting | Cuneo | CN | 12100 | Italy |
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| Azienda Ospedaliera per l'emergenza Cannizzaro | Recruiting | Catania | CT | 95100 | Italy |
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| IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" | Recruiting | Meldola | FC | 47014 | Italy |
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| Azienda Ospedaliero Universitario Careggi | Recruiting | Florence | FI | 50134 | Italy |
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| IRCCS Policlinico San Martino | Recruiting | Genova | GE | 16132 | Italy |
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| Fondazione IRCCS San Gerardo dei Tintori (Monza) | Not yet recruiting | Monza | MB | 20900 | Italy |
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| Università Vita-Salute San Raffaele (IRCCS San Raffaele - Milano) | Recruiting | Milan | MI | 20132 | Italy |
|
| Istituto Nazionale Tumori (INT) - Milano | Recruiting | Milan | MI | 20133 | Italy |
|
| Istituto Oncologico Veneto (IOV) | Recruiting | Padova | PD | 35128 | Italy |
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| Ospedale S. Maria della Misericordia | Recruiting | Perugia | PG | 06156 | Italy |
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| Centro di riferimento oncologico - CRO di Aviano | Recruiting | Aviano | PN | 33081 | Italy |
|
| Istituto Nazionale Tumori Regina Elena - Roma | Recruiting | Roma | RM | 00144 | Italy |
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| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | Roma | RM | 00168 | Italy |
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| Ospedale San Paolo - ASL2 - Savona | Recruiting | Savona | SV | 17100 | Italy |
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| Ospedale Mauriziano Umberto I | Recruiting | Torino | TO | 10128 | Italy |
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| Azienda sanitaria universitaria Friuli Centrale (ASU FC) | Recruiting | Udine | UD | 33100 | Italy |
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| Azienda Ulss 3 Serenissima | Recruiting | Mestre | VE | 30174 | Italy |
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| Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale | Recruiting | Naples | 80131 | Italy |
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| Università degli Studi di Napoli "Federico II" | Recruiting | Naples | 80131 | Italy |
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| Prot_000.pdf |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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