Advanced Ovarian Cancer, Epithelial Ovarian Cancer, Ovarian Neoplasms
Conditions
Keywords
ovarian cancer, Centralization of Care, COVID-19 Pandemic, Surgical Outcomes, Epithelial Ovarian Neoplasms, Progression-Free Survival, Overall Survival, Health Services Reorganization
Brief summary
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.
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.
Interventions
OTHERNo Intervention: Observational Cohort
Observational data collection only
Sponsors
Azienda USL Reggio Emilia - IRCCS
AUSL di Modena - Ospedale Ramazzini di Carpi
AUSL di Modena - Ospedale di Mirandola
AUSL di Modena - Ospedale Civile di Sassuolo
AUSL di Modena - Ospedale di Pavullo nel Frignano
AUSL di Modena - Ospedale di Vignola
Azienda Ospedaliero-Universitaria di Modena
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | Up to 5 years from diagnosis | Time from initial diagnosis of epithelial ovarian cancer to the date of first documented disease progression or death from any cause, whichever occurs first. |
| Overall Survival (OS) | Up to 5 years from diagnosis | Time from initial diagnosis to death from any cause. Patients still alive will be censored at the date of last follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Type of treatment received after initial diagnosis | Within 12 months from 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. |
| Use of targeted therapies (Bevacizumab and/or PARP inhibitors) | Within 12 months from completion of first-line chemotherapy | Percentage of patients treated with Bevacizumab, PARP inhibitors, or both, in adjuvant or maintenance settings. |
| Rate and characteristics of recurrence | Up to 5 years from diagnosis | Frequency, site, and symptoms of disease recurrence, and rate of patients undergoing secondary surgery or radiotherapy. |
| Rate of radiotherapy use in recurrent disease | Up to 5 years from diagnosis | Proportion of patients with recurrence treated with radiotherapy, including treatment site, dose, and clinical response. |
Countries
Italy
Contacts
CONTACTVincenzo Dario Mandato, MD - Principal Investigator
CONTACTJasmine Lonetti
PRINCIPAL_INVESTIGATORVincenzo Dario Mandato, MD
Azienda USL - IRCCS di Reggio Emilia
Outcome results
None listed