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NCT Number: NCT07075939

Centralization and Oncologic Outcomes in Ovarian Cancer

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.

Recruiting

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

No Intervention: Observational Cohort

Other

Observational data collection only

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: 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.

  2. Overall Survival (OS)

    Time frame: 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 outcomes

  1. Type of treatment received after initial diagnosis

    Time frame: 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.

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

    Time frame: Within 12 months from completion of first-line chemotherapy

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

  3. Rate and characteristics of recurrence

    Time frame: Up to 5 years from diagnosis

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

  4. Rate of radiotherapy use in recurrent disease

    Time frame: Up to 5 years from diagnosis

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jasmine Lonetti

CONTACT

[email protected]

+39 0522 295467

Vincenzo Dario Mandato, MD - Principal Investigator

CONTACT

[email protected]

+39 0522 295467

Sponsors and collaborators

Lead sponsor

Azienda USL Reggio Emilia - IRCCS

Other Gov

Collaborators

  • AUSL di Modena - Ospedale Civile di Sassuolo
  • AUSL di Modena - Ospedale Ramazzini di Carpi
  • AUSL di Modena - Ospedale di Mirandola
  • AUSL di Modena - Ospedale di Pavullo nel Frignano
  • AUSL di Modena - Ospedale di Vignola
  • Azienda Ospedaliero-Universitaria di Modena

Registry information

Official study title

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

Acronym: COOC - REMO

Important dates

Study start
2025
Primary completion
2030
Study completion
2031
First posted
Jul 20, 2025
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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