Centralization and Oncologic Outcomes in Ovarian Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-99
SponsorAzienda USL Reggio Emilia - IRCCS
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
No Intervention: Observational Cohort
Other interventionObservational data collection only
Treatment groups
200 Participants
are divided into 3 treatment groupsGroup A: Pre-pandemic cohort (Group A)1 intervention
Group B: Pandemic peak cohort(Group B)1 intervention
Group C: Post-peak pandemic cohort(Group C)1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Up to 5 years from diagnosis2
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.
Time frame
Up to 5 years from diagnosisSecondary outcomes
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.
Time frame
Within 12 months from diagnosis2
Use of targeted therapies (Bevacizumab and/or PARP inhibitors)
Percentage of patients treated with Bevacizumab, PARP inhibitors, or both, in adjuvant or maintenance settings.
Time frame
Within 12 months from completion of first-line chemotherapy3
Rate and characteristics of recurrence
Frequency, site, and symptoms of disease recurrence, and rate of patients undergoing secondary surgery or radiotherapy.
Time frame
Up to 5 years from diagnosis4
Rate of radiotherapy use in recurrent disease
Proportion of patients with recurrence treated with radiotherapy, including treatment site, dose, and clinical response.
Time frame
Up to 5 years from diagnosisSponsors and contacts
Click on the lead sponsor to view all of their trials.
Azienda USL Reggio Emilia - IRCCS
Lead sponsor
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
Source ClinicalTrials.gov