An observational study in Epithelial Ovarian Cancer, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 47 studies in Carcinoma, Ovarian Epithelial with a site in Italy — 13 open to participants now, 19 under way, 8 of them phase 3. Carcinoma, Ovarian Epithelial · Italy.
Among the 47 studies in Carcinoma, Ovarian Epithelial with a site in Italy, this one is one of 4 that started in 2026, is one of 7 observational ones, reaches primary completion later than 5 of the 18 other live ones, and was the 45th registered.
798 studies on the registry are indexed under Carcinoma, Ovarian Epithelial; 102 are open to participants now.
Browse Carcinoma, Ovarian Epithelial studies →13 of the 47 studies in Carcinoma, Ovarian Epithelial with a site in Italy are open now. Recruiting first, the newest first:
AstraZeneca · Sites in Italy, United States, Australia and 10 more countries
Ages 18+ · Women only
AstraZeneca · Sites in Italy, United States, Argentina and 26 more countries
Ages 18+ · Women only
Blue Earth Diagnostics · Sites in Italy, Netherlands
Ages 18–79
AstraZeneca · Sites in Italy, United States, Australia and 21 more countries
Ages 18+ · Women only
Azienda USL Reggio Emilia - IRCCS · Sites in Italy
Ages 18–99 · Women only
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 75 Carcinoma, Ovarian Epithelial studies recruiting now, 50 (67%) set no upper age limit and 12 (16%) stop at 75 or younger; 2 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
47 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 7 · Phase 3 25 · Phase 4 1
First in 1996; this study’s year is marked. 4 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 1,125 is above the median of 200 across 91 observational studies indexed under Carcinoma, Ovarian Epithelial.
Median enrollment 227 across the 38 interventional studies, 200 across the 7 observational. Of the 26 that completed or were terminated, 7 (27%) have results posted.
This tab as a report to print or save as PDF → With an account.
27 of 47 have an industry lead sponsor. The 10 most frequent:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS has 3 studies filed under Carcinoma, Ovarian Epithelial — fewer than ten, so there is no comparison to draw.
6 of the studies in Carcinoma, Ovarian Epithelial with a site in Italy that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04498117Phase 3CanariaBio Inc.Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery | 2026-12-26 |
| NCT07825181Fondazione Policlinico Universitario Agostino Gemelli IRCCSHomologous Recombination Repair Deficiency (HRD) Testing in Newly Diagnosed Advanced-stage Epithelial Ovarian Cancer in Italy | 2027-03 |
| NCT06121401Mario Negri Institute for Pharmacological ResearchFirst Line Treatment With Olaparib in Combination With Bevacizumab in HRD Positive Patients | 2027-03-15 |
| NCT05238922Incyte CorporationStudy of INCB123667 in Subjects With Advanced Solid Tumors | 2027-07-27 |
| NCT06690775TORL Biotherapeutics, LLCCATALINA-2: A Clinical Study of TORL-1-23 in Platinum-resistant Ovarian Cancer. | 2027-10 |
Add all 6 to your calendar (.ics) → With an account.
Among the 47 studies in Carcinoma, Ovarian Epithelial with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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:
Secondary endpoints include:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HRD testing on FFPE samples
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.
Time frame: Through study completion, an average of 1 year
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.
Time frame: Through study completion, an average of 1 year
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
Time frame: Through study completion, an average of 1 year
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.
Time frame: Through study completion, an average of 1 year
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.
Time frame: Through study completion, an average of 1 year
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
Time frame: Through study completion, an average of 1 year
Prevalence of HRD-positive tumors
The proportion of tumors testing HRD-positive will be quantified and reported as both absolute numbers (n/N) and percentages, providing an overall measure of HRD status within the enrolled population.
Time frame: Through study completion, an average of 1 year
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Mar 2027, 6 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Carcinoma, Ovarian Epithelial →
Fondazione Policlinico Universitario Agostino Gemelli IRCCS →