Measure of Outcomes in Patients With Advanced Ovarian Cancer According to Homologous Recombination Status and Matched Therapies in a Real-world Scenario
BeLIVE
1 other identifier
observational
300
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2024
Longer than P75 for all trials
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 13, 2024
CompletedFirst Submitted
Initial submission to the registry
January 8, 2025
CompletedFirst Posted
Study publicly available on registry
February 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2029
February 20, 2025
January 1, 2025
4.3 years
January 8, 2025
February 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Evaluate the clinical outcomes
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
Until 3 years from enrollment
Evaluate the clinical outcomes
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
Until 3 years from enrollment
Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort
Toxicity evaluated according to CTCAE vers 5.0
Until 3 years from enrollment
Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort
Percentage of patients with dose reductions
Until 3 years from enrollment
Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort
Percentage of patients with dose interruptions due to toxicity
Until 3 years from enrollment
Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort
Percentage of patients with treatment discontinuations due to toxicity
Until 3 years from enrollment
Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort
Toxicity according to initial dose of targeted agents
Until 3 years from enrollment
Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort
Incidence of myelodysplastic syndrome and acute myeloid leukaemia in patients receiving PARPi
Until 3 years from enrollment
Secondary Outcomes (5)
Describe the clinical outcomes
Until 3 years from enrollment
Describe the clinical outcomes
Until 3 years from enrollment
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
Study Arms (2)
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.
Cohort B: Homologous Recombination Proficient (HRP)
Homologous Recombination Proficient (HRP) ovarian cancer patients treated as for standard clinical practice at clinician's choice.
Eligibility Criteria
All patients diagnosed with advanced high grade ovarian cancer who have received a homologous recombination analysis using validated HRD test between January 2021 and January 2026 are eligible. Patients resulted HRD and treated with Olaparib plus Bevacizumab will be included in Cohort A while patient with HRP tumors will be included in the Cohort B. Patients enrolled in the "compassionate use" of Olaparib (CNN program) can be included as well as patients who have received therapies according to clinical practice.
You may qualify if:
- 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.
You may not qualify if:
- Patients who have not performed a validated Homologous Recombination test on tumor sample.
- Patients with germline or somatic BRCA 1 or 2 mutations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Istituto Tumori "Giovanni Paolo II" I.R.C.C.S.
Bari, BA, 70124, Italy
Azienda Ospedaliero Universitaria di Bologna - Policlinico S.Orsola-Malpighi
Bologna, BO, 40138, Italy
Azienda Ospedaliera S.Croce e Carle Cuneo
Cuneo, CN, 12100, Italy
Azienda Ospedaliera per l'emergenza Cannizzaro
Catania, CT, 95100, Italy
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola, FC, 47014, Italy
Azienda Ospedaliero Universitario Careggi
Florence, FI, 50134, Italy
IRCCS Policlinico San Martino
Genova, GE, 16132, Italy
Fondazione IRCCS San Gerardo dei Tintori (Monza)
Monza, MB, 20900, Italy
Università Vita-Salute San Raffaele (IRCCS San Raffaele - Milano)
Milan, MI, 20132, Italy
Istituto Nazionale Tumori (INT) - Milano
Milan, MI, 20133, Italy
Istituto Oncologico Veneto (IOV)
Padua, PD, 35128, Italy
Ospedale S. Maria della Misericordia
Perugia, PG, 06156, Italy
Centro di riferimento oncologico - CRO di Aviano
Aviano, PN, 33081, Italy
Istituto Nazionale Tumori Regina Elena - Roma
Roma, RM, 00144, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, RM, 00168, Italy
Ospedale San Paolo - ASL2 - Savona
Savona, SV, 17100, Italy
Ospedale Mauriziano Umberto I
Torino, TO, 10128, Italy
Azienda sanitaria universitaria Friuli Centrale (ASU FC)
Udine, UD, 33100, Italy
Azienda Ulss 3 Serenissima
Mestre, VE, 30174, Italy
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale
Napoli, 80131, Italy
Università degli Studi di Napoli "Federico II"
Napoli, 80131, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2025
First Posted
February 20, 2025
Study Start
September 13, 2024
Primary Completion (Estimated)
January 1, 2029
Study Completion (Estimated)
January 1, 2029
Last Updated
February 20, 2025
Record last verified: 2025-01