Centralization and Oncologic Outcomes in Ovarian Cancer

NCT07075939 | Active Not Recruiting

• 1 other identifier: 247/2025/OSS/AUSLRE
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 7

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.

Conditions

Epithelial Ovarian Cancer; Ovarian Neoplasms; Advanced Ovarian Cancer

Keywords

ovarian cancer; Centralization of Care; COVID-19 Pandemic; Surgical Outcomes; Epithelial Ovarian Neoplasms; Progression-Free Survival; Overall Survival; Health Services Reorganization

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Type of treatment received after initial diagnosis

  Within 12 months from diagnosis

• Use of targeted therapies (Bevacizumab and/or PARP inhibitors)

  Within 12 months from completion of first-line chemotherapy

• Rate and characteristics of recurrence

  Up to 5 years from diagnosis

• Rate of radiotherapy use in recurrent disease

  Up to 5 years from diagnosis

Study Arms (3)

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.

Other: No Intervention: Observational Cohort

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.

Other: No Intervention: Observational Cohort

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.

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

Observational data collection only

Pandemic peak cohort(Group B); Post-peak pandemic cohort(Group C); Pre-pandemic cohort (Group A)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead
• AUSL di Modena - Ospedale Ramazzini di Carpi: collaborator
• AUSL di Modena - Ospedale di Mirandola: collaborator
• AUSL di Modena - Ospedale Civile di Sassuolo: collaborator
• AUSL di Modena - Ospedale di Pavullo nel Frignano: collaborator
• AUSL di Modena - Ospedale di Vignola: collaborator
• Azienda Ospedaliero-Universitaria di Modena: collaborator

Study Sites (7)

Azienda Unità - Sanitaria locale di Modena - Ospedale Razzini Carpi

Carpi, Modena, Italy

Location

Azienda Unità - Sanitaria locale di Modena - Ospedale di Mirandola

Mirandola, Modena, Italy

Location

Azienda Unità - Sanitaria locale di Modena - Ospedale Pavullo nel Frignano

Pavullo nel Frignano, Modena, Italy

Location

Azienda Unità - Sanitaria locale di Modena - Ospedale Civile Sassuolo

Sassuolo, Modena, Italy

Location

Azienda Unità - Sanitaria locale di Modena - Ospedale di Vignola

Vignola, Modena, Italy

Location

Azienda USL IRCCS di Reggio Emilia

Reggio Emilia, RE, 42123, Italy

Location

Azienda Ospedaliero - Universitario di Modena

Modena, Italy

Location

Related Publications (10)

• 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.

  PMID: 21917306 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.

  PMID: 31048403 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.

  PMID: 33538338 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.

  PMID: 32086362 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.

  PMID: 34581889 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.

  PMID: 35969358 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.

  PMID: 23547941 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.

  PMID: 34149908 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.

  PMID: 32275775 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.

  PMID: 37358270 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Ovarian Neoplasms; COVID-19

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Vincenzo Dario Mandato, MD

  Azienda USL - IRCCS di Reggio Emilia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 20, 2025
• Study Start: June 27, 2025
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

IT (7)