Clinical trial NCT06836219: Measure of Outcomes in Patients With Advanced Ovarian Cancer According to Homologous Recombination Status and Matched Therapies in a Real-world Scenario
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Cancer
Keywords: Ovarian Cancer
Homologous Recombination status
Lead sponsor: Consorzio Oncotech
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the clinical outcomes
timeFrame: Until 3 years from enrollment
measure: Evaluate the clinical outcomes
timeFrame: Until 3 years from enrollment
measure: Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort
timeFrame: Until 3 years from enrollment
measure: Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort
timeFrame: Until 3 years from enrollment
measure: Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort
timeFrame: Until 3 years from enrollment
measure: Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort
timeFrame: Until 3 years from enrollment
measure: Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort
timeFrame: Until 3 years from enrollment
measure: Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort
timeFrame: Until 3 years from enrollment
Secondary outcomes:
measure: Describe the clinical outcomes
timeFrame: Until 3 years from enrollment
measure: Describe the clinical outcomes
timeFrame: Until 3 years from enrollment
measure: Describe the clinical outcomes
timeFrame: Until 3 years from enrollment
measure: Describe the clinical characteristics of patients for which the combination therapy was offered (Cohort A)
timeFrame: Until 3 years from enrollment
measure: Describe the treatment approach to HRP patients in a real word scenario in Italy (Cohort B)
timeFrame: Until 3 years from enrollment
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Istituto Tumori "Giovanni Paolo II" I.R.C.C.S.
state: BA
city: Bologna
country: Italy
facility: Azienda Ospedaliero Universitaria di Bologna - Policlinico S.Orsola-Malpighi
state: BO
city: Cuneo
country: Italy
facility: Azienda Ospedaliera S.Croce e Carle Cuneo
state: CN
city: Catania
country: Italy
facility: Azienda Ospedaliera per l'emergenza Cannizzaro
state: CT
city: Meldola
country: Italy
facility: IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
state: FC
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitario Careggi
state: FI
city: Genova
country: Italy
facility: IRCCS Policlinico San Martino
state: GE
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori (Monza)
state: MB
city: Milano
country: Italy
facility: Università Vita-Salute San Raffaele (IRCCS San Raffaele - Milano)
state: MI
city: Milano
country: Italy
facility: Istituto Nazionale Tumori (INT) - Milano
state: MI
city: Padova
country: Italy
facility: Istituto Oncologico Veneto (IOV)
state: PD
city: Perugia
country: Italy
facility: Ospedale S. Maria della Misericordia
state: PG
city: Aviano
country: Italy
facility: Centro di riferimento oncologico - CRO di Aviano
state: PN
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena - Roma
state: RM
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
state: RM
city: Savona
country: Italy
facility: Ospedale San Paolo - ASL2 - Savona
state: SV
city: Torino
country: Italy
facility: Ospedale Mauriziano Umberto I
state: TO
city: Udine
country: Italy
facility: Azienda sanitaria universitaria Friuli Centrale (ASU FC)
state: UD
city: Mestre
country: Italy
facility: Azienda Ulss 3 Serenissima
state: VE
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale
city: Napoli
country: Italy
facility: Università degli Studi di Napoli "Federico II"
Study officials:
References: