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

Recruiting

• Conditions: Ovarian Cancer

• Registration Number: NCT06836219
• Lead Sponsor: Consorzio Oncotech

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.

Study Timeline

• Study Start: 2024-09-13
• Status Verified: 2025-01
• Study First Submitted: 2025-01-08
• Study First Submitted QC: 2025-02-14
• Last Update Submitted: 2025-02-14
• Study First Posted: 2025-02-20
• Last Update Posted: 2025-02-20
• Primary Completion: 2029-01
• Study Completion: 2029-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the clinical outcomes	Until 3 years from enrollment	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	Until 3 years from enrollment	Incidence of myelodysplastic syndrome and acute myeloid leukaemia in patients receiving PARPi

Secondary Outcome Measures

Name	Time	Method
Describe the clinical outcomes	Until 3 years from enrollment	according to residual disease after surgery in each cohort
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)

Trial Locations

Locations (21)

IRCCS Policlinico San Martino; 🇮🇹 Genova, GE, Italy

Istituto Tumori "Giovanni Paolo II" I.R.C.C.S.; 🇮🇹 Bari, BA, Italy

Azienda Ospedaliero Universitaria di Bologna - Policlinico S.Orsola-Malpighi; 🇮🇹 Bologna, BO, Italy

Azienda Ospedaliera S.Croce e Carle Cuneo; 🇮🇹 Cuneo, CN, Italy

Azienda Ospedaliera per l'emergenza Cannizzaro; 🇮🇹 Catania, CT, Italy

IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"; 🇮🇹 Meldola, FC, Italy

Azienda Ospedaliero Universitario Careggi; 🇮🇹 Firenze, FI, Italy

Fondazione IRCCS San Gerardo dei Tintori (Monza); 🇮🇹 Monza, MB, Italy

Università Vita-Salute San Raffaele (IRCCS San Raffaele - Milano); 🇮🇹 Milano, MI, Italy

Istituto Nazionale Tumori (INT) - Milano; 🇮🇹 Milano, MI, Italy

Istituto Oncologico Veneto (IOV); 🇮🇹 Padova, PD, Italy

Ospedale S. Maria della Misericordia; 🇮🇹 Perugia, PG, Italy

Centro di riferimento oncologico - CRO di Aviano; 🇮🇹 Aviano, PN, Italy

Istituto Nazionale Tumori Regina Elena - Roma; 🇮🇹 Roma, RM, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Roma, RM, Italy

Ospedale San Paolo - ASL2 - Savona; 🇮🇹 Savona, SV, Italy

Ospedale Mauriziano Umberto I; 🇮🇹 Torino, TO, Italy

Azienda sanitaria universitaria Friuli Centrale (ASU FC); 🇮🇹 Udine, UD, Italy

Azienda Ulss 3 Serenissima; 🇮🇹 Mestre, VE, Italy

Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale; 🇮🇹 Napoli, Italy

Università degli Studi di Napoli "Federico II"; 🇮🇹 Napoli, Italy