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Centralization and Oncologic Outcomes in Ovarian Cancer: A Multicenter Retrospective and Prospective Observational Study Within the REMO Network (COOC-REMO)
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.
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.
Age
18 - 99 years
Sex
FEMALE
Healthy Volunteers
No
Azienda Unità - Sanitaria locale di Modena - Ospedale Razzini Carpi
Carpi, Modena, Italy
Azienda Unità - Sanitaria locale di Modena - Ospedale di Mirandola
Mirandola, Modena, Italy
Azienda Unità - Sanitaria locale di Modena - Ospedale Pavullo nel Frignano
Pavullo nel Frignano, Modena, Italy
Azienda Unità - Sanitaria locale di Modena - Ospedale Civile Sassuolo
Sassuolo, Modena, Italy
Azienda Unità - Sanitaria locale di Modena - Ospedale di Vignola
Vignola, Modena, Italy
Azienda USL IRCCS di Reggio Emilia
Reggio Emilia, RE, Italy
Azienda Ospedaliero - Universitario di Modena
Modena, Italy
Start Date
June 27, 2025
Primary Completion Date
June 1, 2030
Completion Date
June 1, 2030
Last Updated
July 20, 2025
200
ESTIMATED participants
No Intervention: Observational Cohort
OTHER
Lead Sponsor
Azienda USL Reggio Emilia - IRCCS
Collaborators
NCT07213804
NCT07432633
Data Source & Attribution
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