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Centralization and Oncologic Outcomes in Ovarian Cancer

Centralization and Oncologic Outcomes in Ovarian Cancer

Recruiting
18-99 years
Female
Phase N/A

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Overview

This is a multicenter, observational, retrospective and prospective study conducted within the REMO (Reggio Emilia - Modena) network in the Emilia-Romagna region (Italy), promoted by AUSL-IRCCS of Reggio Emilia.

The study aims to evaluate the impact of surgical centralization and treatment strategies adopted during the COVID-19 pandemic on oncologic outcomes in patients diagnosed with the epithelial ovarian cancer (EOC) from 2018 to 2023.

The retrospective component includes patients treated between 2018 and 2023, while the prospective component consists of clinical follow-up of those patients over the next five years.

Description

Epithelial ovarian cancer (EOC) is a highly aggressive malignancy, frequently diagnosed at an advanced stage and requiring a combined approach of surgery and systemic therapy. Complete cytoreductive surgery remains the most important prognostic factor, as residual disease ≥1 cm significantly worsens survival. In November 2019, a regional decree in Emilia-Romagna (Italy) introduced the centralization of EOC treatment to high-volume centers to improve care quality and clinical outcomes.

Shortly thereafter, the onset of the COVID-19 pandemic led to a severe reduction in healthcare resources, including surgical capacity, ICU beds, and staff availability. This situation resulted in a higher proportion of patients being referred for neoadjuvant chemotherapy, with surgery performed mainly in selected patients with better performance status and higher chances of complete resection. During this period, an increase in centralized treatments, multidisciplinary evaluations, BRCA testing, and use of interval debulking surgery (IDS) was observed.

This observational, retrospective study is designed to evaluate whether centralization and pandemic-related treatment modifications influenced oncological outcomes. The primary objective is to compare progression-free survival (PFS) and overall survival (OS) among patients treated during three different timeframes: pre-centralization/pre-pandemic (2018-2019), peak pandemic phase (2020-2021), and pandemic control phase (2022-2023). Secondary objectives include describing treatment strategies after initial diagnosis (type of surgery, chemotherapy, maintenance therapies), tumor characteristics (histology, BRCA/HRD status), recurrence patterns (site, symptoms, treatment), and the proportion of patients receiving secondary surgery, radiotherapy, Bevacizumab, and/or PARP inhibitors. No experimental interventions are included, and all patients received treatment according to routine clinical practice.

Eligibility

Inclusion Criteria:

  • Female patients aged between 18 and 99 years
  • Histological and/or cytological diagnosis of epithelial ovarian cancer
  • Patients evaluated by the Multidisciplinary Tumor Board (MTB) of the AUSL-IRCCS of Reggio Emilia
  • Patients treated between January 1, 2018, and December 31, 2023
  • Availability of clinical records and outcome data
  • Signed informed consent where possible, in accordance with GDPR and Italian regulations

Exclusion Criteria:

  • Patients without histological or cytological confirmation of epithelial ovarian cancer
  • Incomplete or missing data for key clinical indicators
  • Patients unable to provide informed consent and for whom recontact is not possible
  • Patients deemed unable to understand and provide consent (e.g., severe cognitive impairment)

Study details
    Epithelial Ovarian Cancer
    Ovarian Neoplasms
    Advanced Ovarian Cancer

NCT07075939

Azienda USL Reggio Emilia - IRCCS

25 July 2026

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