Multicenter
study (MCS) office
ClinicalTrials.gov Identifier: NCT05496517
Ovarian cancer (OC) is one of the most common types of malignant tumors and the eighth cause of cancer-related mortality in women. FIGO staging is considered the standard classification system that determines prognosis and management of newly diagnosed OC. However, there are numerous gaps in this staging system that would limit interpretation of clinically relevant data.
Management of ovarian cancer is surgical and comprises bilateral sapling-oophorectomy, total abdominal hysterectomy , and infracolic omentectomy. Additional surgical steps and neoadjuvant therapy are potentially determined by disease characteristics. Extent of surgery and neoadjuvant treatment is directly related to postoperative comorbidities and contributes to long term prognosis. Therefore, development of an individualized prognostic and decision-making system, based on large multicenter studies, would facilitate accurate prediction of disease prognosis and determination of individualized management strategy.
This project aims at creating an individualized prognostic model using patient
characteristics and disease features to determine disease prognosis using machine
learning technology.
The model can be used to determine the optimal management plan per patient in priori and highlight risk and timing of disease recurrence.
The study will comprise at least 8 international cancer centers. Data of patients,
newly diagnosed with OC between January 2010 and December 2016, will be
retrospectively collected. Therefore, a follow-up of at least 5 years would be granted. All women who will be diagnosed with primary ovarian cancer at any stage, of all histological types and grades eligible for the study. All contributing centers should acquire institutional review board (IRB) approval prior to data collection.
Inclusion criteria:
• Women diagnosed with ovarian cancer between January 2010 and December 2016.
• Primary non-recurrent diagnosis of ovarian cancer.
• Women should be diagnosed and managed by the corresponding center.
• Patients with adequate clinical and pathological data
Exclusion criteria:
• Inadequate information and follow-up for at least 5 years.
• Authorization to use anonymous patient data for research purposes.
Data will be collected using an excel spreadsheet designed for this study and shared
Primary outcome of the study will be cancer-specific survival (CSS) rate at 3 and 5
years after initiation of treatment. Recurrence-free survival (RFS) rate at 3 and 5 years constitutes the secondary outcome
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