NCT06836219Recruiting
Measure of Outcomes in Patients With Advanced Ovarian Cancer According to Homologous Recombination Status and Matched Therapies in a Real-world Scenario
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
Source: ClinicalTrials.gov · Last updated 20 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 8 Jan 2025
- Start date
- 13 Sept 2024
- Primary completion date
- Jan 2029
- Lead sponsor
- Consorzio Oncotech
- Diseases
- Ovarian cancer
- NCT number
- NCT06836219
What you commit to
- Study type: Observational
- Planned participants: 300
- From 13 Sept 2024 to the primary completion date, Jan 2029
- 21 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro Di Riferimento Oncologico (CRO) Di Aviano Coordinator of this site? Confirm its status | Aviano | Italy | Recruiting |
| Istituto Tumori "Giovanni Paolo II" I.R.C.C.S. Coordinator of this site? Confirm its status | Bari | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Di Bologna Policlinico S. Orsola Malpighi Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| Azienda Ospedaliera per l Emergenza Cannizzaro Coordinator of this site? Confirm its status | Catania | Italy | Recruiting |
| Azienda Ospedaliera S.Croce e Carle Cuneo Coordinator of this site? Confirm its status | Cuneo | Italy | Recruiting |
| Azienda Ospedaliero Universitario Careggi Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| IRCCS Policlinico San Martino Coordinator of this site? Confirm its status | Genova | Italy | Recruiting |
| IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" Coordinator of this site? Confirm its status | Meldola | Italy | Recruiting |
| Azienda Ulss 3 Serenissima Coordinator of this site? Confirm its status | Mestre | Italy | Recruiting |
| Università Vita-Salute San Raffaele (IRCCS San Raffaele - Milano) Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Istituto Nazionale Tumori (INT) - Milano Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Fondazione IRCCS San Gerardo dei Tintori - Monza Coordinator of this site? Confirm its status | Monza | Italy | Not yet recruiting |
| Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Università degli studi di Napoli Federico II Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Istituto Oncologico Veneto (IOV) Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| Ospedale S. Maria della Misericordia Coordinator of this site? Confirm its status | Perugia | Italy | Recruiting |
| Istituto Nazionale Tumori Regina Elena - Roma Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Ospedale San Paolo - ASL2 - Savona Coordinator of this site? Confirm its status | Savona | Italy | Recruiting |
| Ospedale Mauriziano, Umberto I° Coordinator of this site? Confirm its status | Torino | Italy | Recruiting |
| Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) Coordinator of this site? Confirm its status | Udine | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.