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| Name | Class |
|---|---|
| AUSL di Modena - Ospedale Ramazzini di Carpi | UNKNOWN |
| AUSL di Modena - Ospedale di Mirandola | UNKNOWN |
| AUSL di Modena - Ospedale Civile di Sassuolo | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-pandemic cohort (Group A) | 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. |
| |
| Pandemic peak cohort(Group B) | 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. |
| |
| Post-peak pandemic cohort(Group C) | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention: Observational Cohort | Other | Observational data collection only |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Up to 5 years from diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 12 months from diagnosis |
| Use of targeted therapies (Bevacizumab and/or PARP inhibitors) |
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Inclusion Criteria:
Exclusion Criteria:
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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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| Name | Affiliation | Role |
|---|---|---|
| Vincenzo Dario Mandato, MD | Azienda USL - IRCCS di Reggio Emilia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Unità - Sanitaria locale di Modena - Ospedale Razzini Carpi | Carpi | Modena | Italy | |||
| Azienda Unità - Sanitaria locale di Modena - Ospedale di Mirandola |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21917306 | Background | Chi DS, Musa F, Dao F, Zivanovic O, Sonoda Y, Leitao MM, Levine DA, Gardner GJ, Abu-Rustum NR, Barakat RR. An analysis of patients with bulky advanced stage ovarian, tubal, and peritoneal carcinoma treated with primary debulking surgery (PDS) during an identical time period as the randomized EORTC-NCIC trial of PDS vs neoadjuvant chemotherapy (NACT). Gynecol Oncol. 2012 Jan;124(1):10-4. doi: 10.1016/j.ygyno.2011.08.014. Epub 2011 Sep 13. | |
| 31048403 |
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| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| D010051 | Ovarian Neoplasms |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
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| AUSL di Modena - Ospedale di Pavullo nel Frignano |
| UNKNOWN |
| AUSL di Modena - Ospedale di Vignola | UNKNOWN |
| Azienda Ospedaliero-Universitaria di Modena | OTHER |
Not provided
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Percentage of patients treated with Bevacizumab, PARP inhibitors, or both, in adjuvant or maintenance settings. |
| 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. | 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. | Up to 5 years from diagnosis |
| 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 | 42123 | Italy |
| Azienda Ospedaliero - Universitario di Modena | Modena | Italy |
| Background |
| Colombo N, Sessa C, Bois AD, Ledermann J, McCluggage WG, McNeish I, Morice P, Pignata S, Ray-Coquard I, Vergote I, Baert T, Belaroussi I, Dashora A, Olbrecht S, Planchamp F, Querleu D; ESMO-ESGO Ovarian Cancer Consensus Conference Working Group. ESMO-ESGO consensus conference recommendations on ovarian cancer: pathology and molecular biology, early and advanced stages, borderline tumours and recurrent disease. Int J Gynecol Cancer. 2019 May 7;29(4):728-760. doi: 10.1136/ijgc-2019-000308. |
| 33538338 | Background | Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. |
| 32086362 | Background | Fotopoulou C, Concin N, Planchamp F, Morice P, Vergote I, du Bois A, Querleu D. Quality indicators for advanced ovarian cancer surgery from the European Society of Gynaecological Oncology (ESGO): 2020 update. Int J Gynecol Cancer. 2020 Apr;30(4):436-440. doi: 10.1136/ijgc-2020-001248. Epub 2020 Feb 20. No abstract available. |
| 34581889 | Background | Goenka L, Anandaradje A, Nakka T, Kayal S, Dubashi B, Chaturvedula L, Veena P, Durairaj J, Penumadu P, Ganesan P. The "collateral damage" of the war on COVID-19: impact of the pandemic on the care of epithelial ovarian cancer. Med Oncol. 2021 Sep 28;38(11):137. doi: 10.1007/s12032-021-01588-6. |
| 35969358 | Background | Hudry D, Becourt S, Scambia G, Fagotti A. Primary or Interval Debulking Surgery in Advanced Ovarian Cancer: a Personalized Decision-a Literature Review. Curr Oncol Rep. 2022 Dec;24(12):1661-1668. doi: 10.1007/s11912-022-01318-9. Epub 2022 Aug 15. |
| 23547941 | Background | Mandato VD, Abrate M, De Iaco P, Pirillo D, Ciarlini G, Leoni M, Comerci G, Ventura A, Lenzi B, Amadori A, Rosati F, Martinello R, De Palma R, Ventura C, Belotti LM, Formisano D, La Sala GB; Gynecological Oncology Network of Emilia Romagna Region. Clinical governance network for clinical audit to improve quality in epithelial ovarian cancer management. J Ovarian Res. 2013 Mar 31;6(1):19. doi: 10.1186/1757-2215-6-19. |
| 34149908 | Background | Mandato VD, Torricelli F, Uccella S, Pirillo D, Ciarlini G, Ruffo G, Annunziata G, Manzotti G, Pignata S, Aguzzoli L. An Italian National Survey on Ovarian Cancer Treatment at first diagnosis. There's None so Deaf as those who will not Hear. J Cancer. 2021 May 27;12(15):4443-4454. doi: 10.7150/jca.57894. eCollection 2021. |
| 32275775 | Background | Mandato VD, Aguzzoli L. Management of ovarian cancer during the COVID-19 pandemic. Int J Gynaecol Obstet. 2020 Jun;149(3):382-383. doi: 10.1002/ijgo.13167. Epub 2020 Apr 29. |
| 37358270 | Background | Mandato VD, Torricelli F, Mastrofilippo V, Pellegri C, Cerullo L, Annunziata G, Ciarlini G, Pirillo D, Generali M, D'Ippolito G, Leone C, Bologna A, Gasparini E, Palicelli A, Gelli MC, Silvotti M, Aguzzoli L. Impact of 2 years of COVID-19 pandemic on ovarian cancer treatment in IRCCS-AUSL of Reggio Emilia. Int J Gynaecol Obstet. 2023 Nov;163(2):679-688. doi: 10.1002/ijgo.14937. Epub 2023 Jun 26. |
| D004701 |
| Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |