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Epithelial Ovarian CancerHRD-ItalyNCT07825181

Homologous Recombination Repair Deficiency (HRD) Testing in Newly Diagnosed Advanced-stage Epithelial Ovarian Cancer in Italy

An observational study of Epithelial Ovarian Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The study aims to provide a comprehensive overview of HRD testing practices for epithelial ovarian cancer in Italy. In 2024, approximately 5,423 new cancer diagnoses were estimated in Italy. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Epithelial Ovarian Cancer
What is being tested?
HRD test
How many people
1,125 participants
Where
1 siteItaly
Study dates
Sep 2026to Oct 2027
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: Eligible patients are those who underwent HRD testing at the participating centers (N=7) between January 2022 and December 2024, either at diagnosis in the case of FIGO stage III-IV disease, or at first metastatic recurrence if initially diagnosed at FIGO stage I-II. These centers were selected for their role as national referral hubs for ovarian cancer molecular diagnostics and are geographically distributed across Northern, Central, and Southern Italy, providing a representative overview of current HRD testing practices.

Who may be able to join

  • Women ≥ 18 years old with a histological diagnosis of high grade epithelial ovarian cancer, serous or endometrioid histotype;
  • FIGO stage 2014 III-IV or at first metastatic recurrence if initially diagnosed at FIGO stage I-II;
  • HRD status assessed using SOPHiA DDMTM validated assays at each participating center

Who cannot join

  • HRD assessment not performed in-house and/or other platforms;
  • clinical data not available;
  • laboratory data not available

Trial locations and contacts

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

Camilla Nero, PhD contact

+393333630306

camilla.nero@policlinicogemelli.it

Italy1 site

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome

Other trials in Italy

About this study

Official title: Homologous Recombination Repair Deficiency (HRD) Testing in Newly Diagnosed Advanced-stage Epithelial Ovarian Cancer: Insights From the Italian Testing Landscape (HRD-Italy)

The study aims to provide a comprehensive overview of HRD testing practices for epithelial ovarian cancer in Italy.

In 2024, approximately 5,423 new cancer diagnoses were estimated in Italy. The centers participating in this study collectively manage about 40-50% of all ovarian cancer cases diagnosed annually in the country, offering a robust and representative snapshot of national clinical practice and treatment patterns.

Read more

The promoting center has also been recognized as a referral center for ovarian cancer treatment by the European Society of Gynecologic Oncology, based on the number of patients treated and the quality of treatment parameters. HRD testing is recommended at diagnosis for patients with HGOC, in line with NCCN (ref) and ESMO guidelines (ref), so that treatment decisions, particularly the use of PARP inhibitors, can be informed early in the clinical pathway. Several commercial assays are available, each adopting different approaches to evaluate genomic instability.

Although HRD testing is central to guiding treatment decisions in HGOC, its implementation remains challenging and subject to laboratory variability in methodology and interpretation. Real-world evidence on how frequently HRD results influence clinical management and how these results correlate with other patient or disease characteristics is still limited. This study aims to collect detailed information on patients tested in referral laboratories in Italy and the impact of HRD status on therapeutic choices.

A retrospective analysis will be conducted on a multicenter cohort of HGOC patients who consecutively underwent HRD testing. Since the participating centers treat a substantial proportion of FIGO 2014 stage III-IV HGOC cases nationwide, the study provides an indirect estimate of HRD testing uptake in clinical practice.

Study design: Multicenter (n=7), observational, retrospective, non-profit study co-funded by Astrazeneca Spa Data Source(s): Data will be collected in all participating centers through a GDPR compliant electronic form.

Study Population: 1125 advanced (FIGO stage 2014 III-IV) HGOC patients addressed to HRD testing at multiple centers.

Outcome(s):

Main outcomes include:

  1. Prevalence of HRD-positive tumors;
  2. Association between HRD status and key baseline clinical characteristics;
  3. Treatment choices following HRD determination;

Secondary endpoints include:

  1. Turn-around-time (TAT) for HRD report;
  2. Assay feasibility and reportability;
  3. Correlation between HRD score and continuous clinical measures;
  4. Time-to-event exploratory prognostic outcomes by HRD status (exploratory).

Sample Size Estimations:

Based on an expected HRD positivity rate of 40% among EOC patients, an effective sample size of approximately 1,046 patients (accounting for a 7% drop-out from an initial cohort of 1,125 patients) will allow us to estimate the prevalence with a 95% confidence interval of ±3%. Additionally, this sample size provides over 80% power to detect a 10% difference in HRD positivity rates between subgroups (e.g. different test types) at a significance level of 0.05. Therefore, the proposed sample size is sufficient to achieve the study's objectives and will provide statistically robust and clinically meaningful insights into HRD testing practices in Italy.

Being tested
HRD test
Keywords
epithelial ovarian cancer, HRD
Medical subject headings
Carcinoma, Ovarian Epithelial

What participants receive

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

  • HRD testDiagnostic test

    HRD testing on FFPE samples

What is being measured

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

  1. Association between HRD status and key baseline clinical characteristics

    Comparison of the percentage of patients with HRD-positive versus HRD-negative status according to key baseline clinical and pathological characteristics, including disease stage at initial diagnosis (I-IV), histological subtype, patterns of metastatic spread, and type of prior lines of therapy. Biomarker profiles, including BRCA mutation status, will also be compared when available. Clinical and pathological characteristics will be assessed using medical records, pathology reports, and available molecular/genomic testing results.

    Measured: Through study completion, an average of 1 year

  2. Treatment choices following HRD determination

    Percentage of patients receiving each type of maintenance therapy following HRD testing, including PARP inhibitor monotherapy or combination therapy with bevacizumab. Treatment information will be obtained from medical records.

    Measured: Through study completion, an average of 1 year

Secondary outcomes (4)

  1. Turn-around-time (TAT) for HRD report

    The interval from surgery to finalized HRD report will be measured in calendar days to gauge the practicality of integrating HRD testing into routine care

    Measured: Through study completion, an average of 1 year

  2. Proportion of Samples With a Valid, Reportable HRD Assay Result

    The proportion of samples generating a valid, reportable HRD assay result will be calculated as the number of samples with a valid, reportable HRD assay result divided by the total number of samples submitted for HRD testing.

    Measured: Through study completion, an average of 1 year

  3. Correlation between HRD score and continuous clinical measures

    Where HRD scores are available as continuous values, we will examine their associations with continuous baseline clinical variables (e.g., patient age and tumor-burden proxies such as baseline CA-125 levels) using simple linear regression models. This approach will allow estimation of the direction and magnitude of associations and assessment of linear trends across the range of HRD scores.

    Measured: Through study completion, an average of 1 year

  4. Time-to-event exploratory prognostic outcomes by HRD status (exploratory)

    To generate hypotheses for future studies, progression-free survival (PFS) and overall survival (OS) will be analyzed according to HRD status. These exploratory time-to-event analyses aim to provide preliminary insights into whether HRD positivity confers prognostic or predictive value beyond immediate treatment choice

    Measured: Through study completion, an average of 1 year

Timeline

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

  1. First posted17 Sep 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionMar 2027 (estimated)
  4. Study completionOct 2027 (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
Retrospective
Enrolment
1,125 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07825181
Sponsor's protocol ID
22129
Acronym
HRD-Italy
Status last verified
Sep 2026
First submitted
3 Sep 2026
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Epithelial Ovarian Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site 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 3 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: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 Camilla Nero, PhD (+393333630306, camilla.nero@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Association between HRD status and key baseline clinical characteristics (time frame: Through study completion, an average of 1 year). The study lists 2 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 NCT07825181.

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 17 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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