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NCT Number: NCT06836219

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Evaluate the clinical outcomes

    Time frame: Until 3 years from enrollment

    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

  2. Evaluate the clinical outcomes

    Time frame: 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

  3. Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort

    Time frame: Until 3 years from enrollment

    Toxicity evaluated according to CTCAE vers 5.0

  4. Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort

    Time frame: Until 3 years from enrollment

    Percentage of patients with dose reductions

  5. Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort

    Time frame: Until 3 years from enrollment

    Percentage of patients with dose interruptions due to toxicity

  6. Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort

    Time frame: Until 3 years from enrollment

    Percentage of patients with treatment discontinuations due to toxicity

  7. Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort

    Time frame: Until 3 years from enrollment

    Toxicity according to initial dose of targeted agents

  8. Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort

    Time frame: Until 3 years from enrollment

    Incidence of myelodysplastic syndrome and acute myeloid leukaemia in patients receiving PARPi

Secondary outcomes

  1. Describe the clinical outcomes

    Time frame: Until 3 years from enrollment

    according to disease stage

  2. Describe the clinical outcomes

    Time frame: Until 3 years from enrollment

    according to surgical timing

  3. Describe the clinical outcomes

    Time frame: Until 3 years from enrollment

    according to residual disease after surgery in each cohort

  4. Describe the clinical characteristics of patients for which the combination therapy was offered (Cohort A)

    Time frame: Until 3 years from enrollment

    Describe the clinical characteristics of patients for which the combination therapy was offered (Cohort A)

  5. Describe the treatment approach to HRP patients in a real word scenario in Italy (Cohort B)

    Time frame: Until 3 years from enrollment

    Describe the treatment approach to HRP patients in a real word scenario in Italy (Cohort B)

Study contacts

Contact information is provided by the study sponsor or research team.

BeLIVE S BeLIVE Service

CONTACT

[email protected]

Michele B Michele Bartoletti, MD

CONTACT

[email protected]

+39 334 500 7736 ext. 334 500 7736

Sponsors and collaborators

Lead sponsor

Consorzio Oncotech

Other

Registry information

Official study title

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

Acronym: BeLIVE

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Feb 20, 2025
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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