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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 21
- 主要终点
- Evaluate the clinical outcomes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Evaluate the clinical outcomes
时间窗: 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
时间窗: Until 3 years from enrollment
Incidence of myelodysplastic syndrome and acute myeloid leukaemia in patients receiving PARPi
次要结局
- Describe the clinical outcomes(Until 3 years from enrollment)
- 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)(Until 3 years from enrollment)