Centralization and Oncologic Outcomes in Ovarian Cancer (COOC - REMO)

Azienda USL Reggio Emilia - IRCCS

Status: Active, not recruiting

Conditions: Ovarian Neoplasms; Epithelial Ovarian Cancer; Advanced Ovarian Cancer

Treatments: Other: No Intervention: Observational Cohort

Study type: Observational

Funder types: Other

Identifiers

NCT07075939

247/2025/OSS/AUSLRE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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)

Trial design

200 participants in 3 patient groups

Pre-pandemic cohort (Group A)

Description:

Patients with epithelial ovarian cancer treated between January 2018 and December 2019, before the implementation of centralization policies and before the onset of the COVID-19 pandemic. Standard care was provided based on local resources and clinical practice guidelines at the time.

Treatment:

Other: No Intervention: Observational Cohort

Pandemic peak cohort(Group B)

Description:

Patients treated between January 2020 and December 2021, during the most critical phase of the COVID-19 pandemic. Centralization of care and multidisciplinary decision-making were consistently applied.Treatment decisions were influenced by reduced hospital resources, increased use of neoadjuvant chemotherapy, and enhanced centralization of surgical procedures.

Treatment:

Other: No Intervention: Observational Cohort

Post-peak pandemic cohort(Group C)

Description:

Patients treated between January 2022 and December 2023, during the phase of pandemic control. Centralization of care and multidisciplinary decision-making were consistently applied. This group reflects the new post-pandemic organizational standards.

Treatment:

Other: No Intervention: Observational Cohort