Official Title
Centralization and Oncologic Outcomes in Ovarian Cancer: A Multicenter Retrospective and Prospective Observational Study Within the REMO Network (COOC-REMO)
Brief Summary

This is a multicenter, observational, retrospective and prospective study conductedwithin 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 strategiesadopted during the COVID-19 pandemic on oncologic outcomes in patients diagnosed with theepithelial ovarian cancer (EOC) from 2018 to 2023.The retrospective component includes patients treated between 2018 and 2023, while theprospective component consists of clinical follow-up of those patients over the next fiveyears.

Detailed 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.

Active, not recruiting
Epithelial Ovarian Cancer
Ovarian Neoplasms
Advanced Ovarian Cancer

Other: No Intervention: Observational Cohort

Observational data collection only

Eligibility Criteria

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)

Eligibility Gender
Female
Eligibility Age
Minimum: 18 Years ~ Maximum: 99 Years
Countries
Italy
Locations

Azienda Unità - Sanitaria locale di Modena - Ospedale Razzini Carpi
Carpi 3180445, Modena, Italy

Azienda Unità - Sanitaria locale di Modena - Ospedale di Mirandola
Mirandola 3173370, Modena, Italy

Azienda Unità - Sanitaria locale di Modena - Ospedale Pavullo nel Frignano
Pavullo nel Frignano 3171355, Modena, Italy

Azienda Unità - Sanitaria locale di Modena - Ospedale Civile Sassuolo
Sassuolo 3167053, Modena, Italy

Azienda Unità - Sanitaria locale di Modena - Ospedale di Vignola
Vignola 3164342, Modena, Italy

Azienda USL IRCCS di Reggio Emilia
Reggio Emilia 3169522, RE, Italy

Azienda Ospedaliero - Universitario di Modena
Modena 3173331, Italy

Vincenzo Dario Mandato, MD, Principal Investigator
Azienda USL - IRCCS di Reggio Emilia

Azienda USL Reggio Emilia - IRCCS
NCT Number
Keywords
Ovarian cancer
Centralization of Care
COVID-19 pandemic
Surgical Outcomes
Epithelial Ovarian Neoplasms
Progression-Free Survival
Overall Survival
Health Services Reorganization
MeSH Terms
Carcinoma, Ovarian Epithelial
Ovarian Neoplasms
COVID-19