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Measure of Outcomes in Patien...

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

Last Updated: 2025-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-13

Study Completion Date

2029-01-31

Brief Summary

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Detailed Description

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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 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.

Conditions

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Ovarian Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

No interventions assigned to this group

Cohort B: Homologous Recombination Proficient (HRP)

Homologous Recombination Proficient (HRP) ovarian cancer patients treated as for standard clinical practice at clinician's choice.

No interventions assigned to this group

Eligibility Criteria

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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 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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers