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

NCT07825181 | Not Yet Recruiting

• 1 other identifier: 22129
• Study Type: observational
• Target: 1,125
• Locations: 1 country
• Sites: 1

Brief 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. 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:

1. 1.Prevalence of HRD-positive tumors;
2. 2.Association between HRD status and key baseline clinical characteristics;
3. 3.Treatment choices following HRD determination;
4. 4.Turn-around-time (TAT) for HRD report;
5. 5.Assay feasibility and reportability;
6. 6.Correlation between HRD score and continuous clinical measures;
7. 7.Time-to-event exploratory prognostic outcomes by HRD status (exploratory).

Conditions

Epithelial Ovarian Cancer

Keywords

epithelial ovarian cancer; HRD

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Through study completion, an average of 1 year

Secondary Outcomes (4)

• Turn-around-time (TAT) for HRD report

  Through study completion, an average of 1 year

• Proportion of Samples With a Valid, Reportable HRD Assay Result

  Through study completion, an average of 1 year

• Correlation between HRD score and continuous clinical measures

  Through study completion, an average of 1 year

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

  Through study completion, an average of 1 year

Other Outcomes (1)

• Prevalence of HRD-positive tumors

  Through study completion, an average of 1 year

Interventions

HRD test DIAGNOSTIC_TEST

HRD testing on FFPE samples

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• AstraZeneca: collaborator

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

FFPE

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Camilla Nero

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camilla Nero, PhD

CONTACT

+393333630306; camilla.nero@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 17, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 17, 2026

Record last verified: 2026-09

Locations

IT (1)