Centralization and Oncologic Outcomes in Ovarian Cancer: A Multicenter Retrospective and Prospective Observational Study Within the REMO Network (COOC-REMO)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: No Intervention: Observational Cohort (Other)
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.
干预措施: No Intervention: Observational Cohort (Other)
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.
干预措施: No Intervention: Observational Cohort (Other)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: 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)
时间窗: 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.
次要结局
- 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)