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Epithelial Ovarian CancerCOOC - REMONCT07075939

Centralization and Oncologic Outcomes in Ovarian Cancer

An observational study of Epithelial Ovarian Cancer and Ovarian Neoplasms, run by Azienda USL Reggio Emilia - IRCCS at 7 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years, women only
How many people
200 participants
Where
7 sitesItaly
Study dates
27 Jun 2025to Jun 2031
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Vincenzo Dario Mandato, MD - Principal Investigator contact

+39 0522 295467

vincenzodario.mandato@ausl.re.it

Jasmine Lonetti contact

+39 0522 295467

jasmine.lonetti@ausl.re.it

7 sites in 1 country

Italy7 sites, 7 recruiting

  • Azienda Unità - Sanitaria locale di Modena - Ospedale Razzini Carpi

    Carpi, Modena

    Donatella Giardina, MD

    Recruiting

  • Azienda Unità - Sanitaria locale di Modena - Ospedale di Mirandola

    Mirandola, Modena

    Donatella Giardina, MD

    Recruiting

  • Azienda Ospedaliero - Universitario di Modena

    Modena

    Cinzia Baldessari, MD

    Recruiting

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

    Pavullo nel Frignano, Modena

    Eleonora Molinaro, MD

    Not yet recruiting

  • Azienda USL IRCCS di Reggio Emilia

    Reggio Emilia, RE, 42123

    Vincenzo Dario Mandato, MD PhD, +39 0522 295467, vincenzodario.mandato@ausl.re.it

    Jasmine Lonetti, Clinical Research Coordinator, +39 0522 295467, jasmine.lonetti@ausl.re.it

    Recruiting

  • Azienda Unità - Sanitaria locale di Modena - Ospedale Civile Sassuolo

    Sassuolo, Modena

    Eleonora Molinaro, MD

    Recruiting

  • Azienda Unità - Sanitaria locale di Modena - Ospedale di Vignola

    Vignola, Modena

    Eleonora Molinaro, MD

    Not yet recruiting

Other trials in Italy

About this study

Official title: Centralization and Oncologic Outcomes in Ovarian Cancer: A Multicenter Retrospective and Prospective Observational Study Within the REMO Network (COOC-REMO)

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.

Read the 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.

Being tested
No Intervention: Observational Cohort
Keywords
ovarian cancer, Centralization of Care, COVID-19 Pandemic, Surgical Outcomes, Epithelial Ovarian Neoplasms, Progression-Free Survival, Overall Survival, Health Services Reorganization
Medical subject headings
Carcinoma, Ovarian Epithelial, Ovarian Neoplasms, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No Intervention: Observational CohortOther

    Observational data collection only

Study groups in NCT07075939
Study groupRoleWhat they receive
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.
Receives: 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.
Receives: 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.
Receives: Other: No Intervention: Observational Cohort

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 5 years from diagnosis

  2. 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.

    Measured: Up to 5 years from diagnosis

Secondary outcomes (4)

  1. 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.

    Measured: Within 12 months from diagnosis

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

    Percentage of patients treated with Bevacizumab, PARP inhibitors, or both, in adjuvant or maintenance settings.

    Measured: Within 12 months from completion of first-line chemotherapy

  3. Rate and characteristics of recurrence

    Frequency, site, and symptoms of disease recurrence, and rate of patients undergoing secondary surgery or radiotherapy.

    Measured: Up to 5 years from diagnosis

  4. Rate of radiotherapy use in recurrent disease

    Proportion of patients with recurrence treated with radiotherapy, including treatment site, dose, and clinical response.

    Measured: Up to 5 years from diagnosis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2025
  2. Study start27 Jun 2025
  3. Primary completionJun 2030 (estimated)
  4. Study completionJun 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07075939
Sponsor's protocol ID
247/2025/OSS/AUSLRE
Acronym
COOC - REMO
Status last verified
Jul 2026
First submitted
11 Jul 2025
Last updated
24 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 21917306

  • 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.

    PubMed 31048403

  • 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.

    PubMed 33538338

  • 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.

    PubMed 32086362

  • 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.

    PubMed 34581889

  • 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.

    PubMed 35969358

  • 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.

    PubMed 23547941

  • 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.

    PubMed 34149908

  • 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.

    PubMed 32275775

  • 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.

    PubMed 37358270

Questions about this trial

What is this clinical trial studying?

An observational study of Epithelial Ovarian Cancer and Ovarian Neoplasms, run by Azienda USL Reggio Emilia - IRCCS at 7 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vincenzo Dario Mandato, MD - Principal Investigator (+39 0522 295467, vincenzodario.mandato@ausl.re.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: Up to 5 years from diagnosis). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07075939, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.

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