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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
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

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centro Di Riferimento Oncologico (CRO) Di Aviano
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AvianoItalyRecruiting
Istituto Tumori "Giovanni Paolo II" I.R.C.C.S.
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BariItalyRecruiting
Azienda Ospedaliero Universitaria Di Bologna Policlinico S. Orsola Malpighi
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BolognaItalyRecruiting
Azienda Ospedaliera per l Emergenza Cannizzaro
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CataniaItalyRecruiting
Azienda Ospedaliera S.Croce e Carle Cuneo
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CuneoItalyRecruiting
Azienda Ospedaliero Universitario Careggi
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FlorenceItalyRecruiting
IRCCS Policlinico San Martino
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GenovaItalyRecruiting
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
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MeldolaItalyRecruiting
Azienda Ulss 3 Serenissima
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MestreItalyRecruiting
Università Vita-Salute San Raffaele (IRCCS San Raffaele - Milano)
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MilanItalyRecruiting
Istituto Nazionale Tumori (INT) - Milano
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MilanItalyRecruiting
Fondazione IRCCS San Gerardo dei Tintori - Monza
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MonzaItalyNot yet recruiting
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
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NaplesItalyRecruiting
Università degli studi di Napoli Federico II
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NaplesItalyRecruiting
Istituto Oncologico Veneto (IOV)
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PadovaItalyRecruiting
Ospedale S. Maria della Misericordia
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PerugiaItalyRecruiting
Istituto Nazionale Tumori Regina Elena - Roma
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RomaItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomaItalyRecruiting
Ospedale San Paolo - ASL2 - Savona
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SavonaItalyRecruiting
Ospedale Mauriziano, Umberto I°
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TorinoItalyRecruiting
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)
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UdineItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.