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Ovarian CancerBeLIVENCT06836219

Measure of Outcomes in Patients With Advanced Ovarian Cancer According to Homologous Recombination Status and Matched Therapies in a Real-world Scenario

An observational study of Ovarian Cancer, run by Consorzio Oncotech at 21 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
How many people
300 participants
Where
21 sitesItaly
Study dates
13 Sep 2024to Jan 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

21 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Michele B Michele Bartoletti, MD contact

+39 334 500 7736 ext. 334 500 7736

michele.bartoletti@cro.it

BeLIVE S BeLIVE Service contact

belive@cr-technology.com

21 sites in 1 country

Italy21 sites, 21 recruiting

  • Centro di riferimento oncologico - CRO di Aviano

    Aviano, PN, 33081

    Michele B Michele Bartoletti, MD, +39 334 500 7736 ext. +39 334 500 77, michele.bartoletti@cro.it

    Recruiting

  • Istituto Tumori "Giovanni Paolo II" I.R.C.C.S.

    Bari, BA, 70124

    Gennaro C Gennaro Cormio, MD, 080 5555910 ext. 080 5555910, gennaro.cormio@uniba.it

    Recruiting

  • Azienda Ospedaliero Universitaria di Bologna - Policlinico S.Orsola-Malpighi

    Bologna, BO, 40138

    Claudio Z Claudio Zamagni, MD, 051 6361259 ext. 051 6361259, claudio.zamagni@aosp.bo.it

    Recruiting

  • Azienda Ospedaliera per l'emergenza Cannizzaro

    Catania, CT, 95100

    Giuseppa S Giuseppa Scandurra, 09 57264135 ext. 09 57264135, giusy.scandurra@gmail.com

    Recruiting

  • Azienda Ospedaliera S.Croce e Carle Cuneo

    Cuneo, CN, 12100

    Lorenza P Lorenza Palmero, MD, Palmero.l@ospedale.cuneo.it

    Recruiting

  • Azienda Ospedaliero Universitario Careggi

    Florence, FI, 50134

    Maria Cristina P Maria Cristina Petrella, MD, 05 579469171 ext. 05 579469171, mariacristina.petrella@gmail.com

    Recruiting

  • IRCCS Policlinico San Martino

    Genova, GE, 16132

    Serafina M Serafina Mammoliti, MD, serafina.mammoliti@hsanmartino.it

    Recruiting

  • IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

    Meldola, FC, 47014

    Alberto F Alberto Farolfi, MD, 0543 739100 ext. 0543 739100, alberto.farolfi@irst.emr.it

    Recruiting

  • Azienda Ulss 3 Serenissima

    Mestre, VE, 30174

    Alessandra B Alessandra Baldoni, MD, 041 5794002 ext. 041 5794002, alessandra.baldoni@aulss3.veneto.it

    Recruiting

  • Università Vita-Salute San Raffaele (IRCCS San Raffaele - Milano)

    Milan, MI, 20132

    Alice B Alice Bergamini, MD, 022 643 5595 ext. 022 643 5595, bergamini.alice@unisr.it

    Recruiting

  • Istituto Nazionale Tumori (INT) - Milano

    Milan, MI, 20133

    Mara M Mara Mantiero, MD, 02 23902507 ext. 02 23902507, mara.mantiero@istitutotumori.mi.it

    Recruiting

  • Fondazione IRCCS San Gerardo dei Tintori (Monza)

    Monza, MB, 20900

    Robert F Robert Fruscio, MD, robert.fruscio@unimib.it

    Not yet recruiting

  • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale

    Naples, 80131

    Sabrina Chiara C Sabrina Chiara Cecere, MD, 081 1777 0472 ext. 081 1777 0472, s.cecere@istitutotumori.na.it

    Recruiting

  • Università degli Studi di Napoli "Federico II"

    Naples, 80131

    Roberto B Roberto Bianco, MD, 081 7461111 ext. 081 7461111, robianco@unina.it

    Recruiting

  • Istituto Oncologico Veneto (IOV)

    Padova, PD, 35128

    Giulia T Giulia Tasca, MD, 04 98215931 ext. 04 98215931, giulia.tasca@iov.veneto.it

    Recruiting

  • Ospedale S. Maria della Misericordia

    Perugia, PG, 06156

    Annamaria M Annamaria Mosconi, MD, 07 55784099 ext. 07 55784099, annamaria.mosconi@ospedale.perugia.it

    Recruiting

  • Istituto Nazionale Tumori Regina Elena - Roma

    Roma, RM, 00144

    Antonella S Antonella Savarese, MD, 06 52666919 ext. 06 52666919, antonella.savarese@ifo.it

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, RM, 00168

    Claudia M Claudia Marchetti, MD, 06 30158556 ext. 06 30158556, claudia.marchetti@policlinicogemelli.it

    Recruiting

  • Ospedale San Paolo - ASL2 - Savona

    Savona, SV, 17100

    Sara Elena R Sara Elena Rebuzzi, se.rebuzzi@asl2.liguria.it

    Recruiting

  • Ospedale Mauriziano Umberto I

    Torino, TO, 10128

    Giorgio V Giorgio Valabrega, MD, +39 0115082046 ext. +39 0115082046, giorgio.valabrega@unito.it

    Recruiting

  • Azienda sanitaria universitaria Friuli Centrale (ASU FC)

    Udine, UD, 33100

    Claudia A Claudia Andreetta, MD, 04 32552754 ext. 04 32552754, claudia.andreetta@asufc.sanita.fvg.it

    Recruiting

Other trials in Italy

About this study

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

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.
Read the 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.

Conditions
Ovarian Cancer
Keywords
Ovarian Cancer, Homologous Recombination status
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06836219
Study groupRoleWhat they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Until 3 years from enrollment

  2. 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

    Measured: Until 3 years from enrollment

  3. Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort

    Toxicity evaluated according to CTCAE vers 5.0

    Measured: Until 3 years from enrollment

  4. Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort

    Percentage of patients with dose reductions

    Measured: Until 3 years from enrollment

  5. Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort

    Percentage of patients with dose interruptions due to toxicity

    Measured: Until 3 years from enrollment

  6. Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort

    Percentage of patients with treatment discontinuations due to toxicity

    Measured: Until 3 years from enrollment

  7. Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort

    Toxicity according to initial dose of targeted agents

    Measured: Until 3 years from enrollment

  8. 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

    Measured: Until 3 years from enrollment

Secondary outcomes (5)

  1. Describe the clinical outcomes

    according to disease stage

    Measured: Until 3 years from enrollment

  2. Describe the clinical outcomes

    according to surgical timing

    Measured: Until 3 years from enrollment

  3. Describe the clinical outcomes

    according to residual disease after surgery in each cohort

    Measured: Until 3 years from enrollment

  4. Describe the clinical characteristics of patients for which the combination therapy was offered (Cohort A)

    Describe the clinical characteristics of patients for which the combination therapy was offered (Cohort A)

    Measured: Until 3 years from enrollment

  5. Describe the treatment approach to HRP patients in a real word scenario in Italy (Cohort B)

    Describe the treatment approach to HRP patients in a real word scenario in Italy (Cohort B)

    Measured: Until 3 years from enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2025
  2. Study start13 Sep 2024
  3. Primary completionJan 2029 (estimated)
  4. Study completionJan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06836219
Sponsor's protocol ID
BeLIVE
Acronym
BeLIVE
Status last verified
Jan 2025
First submitted
8 Jan 2025
Last updated
20 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Ovarian Cancer, run by Consorzio Oncotech at 21 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michele B Michele Bartoletti, MD (+39 334 500 7736 ext. 334 500 7736, michele.bartoletti@cro.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the clinical outcomes (time frame: Until 3 years from enrollment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06836219.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.

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