An observational study in Epithelial Ovarian Cancer, Ovarian Neoplasms and Advanced Ovarian Cancer, sponsored by Azienda USL Reggio Emilia - IRCCS. Recruiting at 7 sites in Italy. Open to female participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by Azienda USL Reggio Emilia - IRCCS · Observational
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.
797 studies on the registry are indexed under Carcinoma, Ovarian Epithelial; 101 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 91 observational studies indexed under Carcinoma, Ovarian Epithelial.
Browse Carcinoma, Ovarian Epithelial studies →Azienda USL Reggio Emilia - IRCCS is the lead sponsor of 93 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women diagnosed with epithelial ovarian cancer between January 2018 and December 2023, treated in the REMO oncological network (Reggio Emilia and Modena, Italy). Patients will be identified through retrospective review of clinical records and prospective follow-up data.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: No Intervention: Observational Cohort
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.
Other: No Intervention: Observational Cohort
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.
Other: No Intervention: Observational Cohort
Observational data collection only
Progression-Free Survival (PFS)
Time from initial diagnosis of epithelial ovarian cancer to the date of first documented disease progression or death from any cause, whichever occurs first.
Time frame: Up to 5 years from diagnosis
Overall Survival (OS)
Time from initial diagnosis to death from any cause. Patients still alive will be censored at the date of last follow-up.
Time frame: Up to 5 years from diagnosis
Type of treatment received after initial diagnosis
Classification of treatment pathways including type of surgery (primary or interval debulking), type of chemotherapy (neoadjuvant, adjuvant, or palliative), and use of maintenance therapies.
Time frame: Within 12 months from diagnosis
Use of targeted therapies (Bevacizumab and/or PARP inhibitors)
Percentage of patients treated with Bevacizumab, PARP inhibitors, or both, in adjuvant or maintenance settings.
Time frame: Within 12 months from completion of first-line chemotherapy
Rate and characteristics of recurrence
Frequency, site, and symptoms of disease recurrence, and rate of patients undergoing secondary surgery or radiotherapy.
Time frame: Up to 5 years from diagnosis
Rate of radiotherapy use in recurrent disease
Proportion of patients with recurrence treated with radiotherapy, including treatment site, dose, and clinical response.
Time frame: Up to 5 years from diagnosis
Started Jun 2025 (actual). Primary completion is estimated for Jun 2030, 60 months after the start.
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Carcinoma, Ovarian Epithelial →
Azienda USL Reggio Emilia - IRCCS