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

Официальное название

Measure of Outcomes in Patients With Advanced Ovarian Cancer According to Homologous Recombination Status and Matched Therapies in a Real-world Scenario: A Retrospective and Prospective, Multicenter, Two Cohorts Study

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Evaluate the clinical outcomes [Срок оценки: Until 3 years from enrollment]
• Evaluate the clinical outcomes [Срок оценки: Until 3 years from enrollment]
• Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort [Срок оценки: Until 3 years from enrollment]
• Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort [Срок оценки: Until 3 years from enrollment]
• Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort [Срок оценки: Until 3 years from enrollment]
• Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort [Срок оценки: Until 3 years from enrollment]
• Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort [Срок оценки: Until 3 years from enrollment]
• Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort [Срок оценки: Until 3 years from enrollment]

Вторичные конечные точки (5)

• Describe the clinical outcomes [Срок оценки: Until 3 years from enrollment]
• Describe the clinical outcomes [Срок оценки: Until 3 years from enrollment]
• Describe the clinical outcomes [Срок оценки: Until 3 years from enrollment]
• Describe the clinical characteristics of patients for which the combination therapy was offered (Cohort A) [Срок оценки: Until 3 years from enrollment]
• Describe the treatment approach to HRP patients in a real word scenario in Italy (Cohort B) [Срок оценки: Until 3 years from enrollment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 21 центр

• Istituto Tumori "Giovanni Paolo II" I.R.C.C.S. — Bari
• Azienda Ospedaliero Universitaria di Bologna - Policlinico S.Orsola-Malpighi — Bologna
• Azienda Ospedaliera S.Croce e Carle Cuneo — Cuneo
• Azienda Ospedaliera per l'emergenza Cannizzaro — Catania
• IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" — Meldola
• Azienda Ospedaliero Universitario Careggi — Florence
• IRCCS Policlinico San Martino — Genova
• Fondazione IRCCS San Gerardo dei Tintori (Monza) — Monza
• … и ещё 13 центров

Идентификаторы

NCT: NCT06836219 · BeLIVE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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