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

Status: Recruiting
Location: See all (21) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Centro di riferimento oncologico - CRO di Aviano
RECRUITING
Aviano
Istituto Tumori Giovanni Paolo II I.R.C.C.S.
RECRUITING
Bari
Azienda Ospedaliero Universitaria di Bologna - Policlinico S.Orsola-Malpighi
RECRUITING
Bologna
Azienda Ospedaliera per l'emergenza Cannizzaro
RECRUITING
Catania
Azienda Ospedaliera S.Croce e Carle Cuneo
RECRUITING
Cuneo
Azienda Ospedaliero Universitario Careggi
RECRUITING
Florence
IRCCS Policlinico San Martino
RECRUITING
Genova
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori
RECRUITING
Meldola
Azienda Ulss 3 Serenissima
RECRUITING
Mestre
Istituto Nazionale Tumori (INT) - Milano
RECRUITING
Milan
Università Vita-Salute San Raffaele (IRCCS San Raffaele - Milano)
RECRUITING
Milan
Fondazione IRCCS San Gerardo dei Tintori (Monza)
NOT_YET_RECRUITING
Monza
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
RECRUITING
Napoli
Università degli Studi di Napoli Federico II
RECRUITING
Napoli
Istituto Oncologico Veneto (IOV)
RECRUITING
Padua
Ospedale S. Maria della Misericordia
RECRUITING
Perugia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING
Roma
Istituto Nazionale Tumori Regina Elena - Roma
RECRUITING
Roma
Ospedale San Paolo - ASL2 - Savona
RECRUITING
Savona
Ospedale Mauriziano Umberto I
RECRUITING
Torino
Azienda sanitaria universitaria Friuli Centrale (ASU FC)
RECRUITING
Udine
Contact Information
Primary
Michele B Michele Bartoletti, MD
michele.bartoletti@cro.it
+39 334 500 7736
Backup
BeLIVE S BeLIVE Service
belive@cr-technology.com
Time Frame
Start Date: 2024-09-13
Estimated Completion Date: 2029-01
Participants
Target number of participants: 300
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Consorzio Oncotech

This content was sourced from clinicaltrials.gov

Similar Clinical Trials