Ovarian carcinoma is the most lethal gynecological malignancy. Epithelial ovarian carcinoma is the gynecological malignancy with the highest mortality rate. The prognosis of patients with recurrent disease is highly heterogeneous and is typically poor in cases of ovarian carcinoma with a progression-free survival (PFS) ≤ 6 months, for which therapeutic options are limited. However, it has been shown that patients with a PFS ≤ 6 months may not respond effectively to further treatments, whereas, conversely, patients with a PFS \> 6 months could still benefit from them. The classification of patients with recurrent disease has undergone continuous evolution over time. Essential factors to consider include patient characteristics, disease stage, and the precise genetic and molecular profile of the tumor. This study aims to evaluate survival in patients experiencing recurrence of epithelial ovarian carcinoma with an unfavorable prognosis, with the objective of improving patient categorization and management.
The study is a collection of clinical-pathological and prognostic data from patients with recurrent epithelial ovarian carcinoma with a progression-free survival of ≤ 6 months. All patients, identified consecutively, will be registered by the investigators, after verification of the eligibility criteria. The requested data will be recorded in a specific anonymous database. The physician will be asked to complete all the database entries that will be analyzed to evaluate the primary and secondary endpoints.
Study Type
OBSERVATIONAL
Enrollment
50
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy
RECRUITINGCharacteristic 1 of patients
Weight (Kg) expressed as mean and standard deviation or median and interquartile range, as appropriate.
Time frame: 2 years
Characteristic 2 of patients
Height (cm) expressed as mean and standard deviation or median and interquartile range, as appropriate.
Time frame: 2 years
Characteristic 3 of patients
Age (years) expressed as mean and standard deviation or median and interquartile range, as appropriate.
Time frame: 2 years
Characteristic 4 of patients
ca 125 levels (U/mL) expressed as mean and standard deviation or median and interquartile range, as appropriate.
Time frame: 2 years
Characteristic 5 of patients
Tumor stage (1-2-3-4) expressed as absolute and percentage frequency.
Time frame: 2 years
Characteristic 6 of patients
histotype (HGSOC, LGSOC, HG endometrioid, LG endometrioid, clear cell, other) expressed as absolute and percentage frequency.
Time frame: 2 years
Characteristic 7 of patients
molecular profiling (HRD positive, HRD negative) expressed as absolute and percentage frequency.
Time frame: 2 years
Characteristic 8 of patients
mutation of BRCA ½ (mutation, wild type) expressed as absolute and percentage frequency.
Time frame: 2 years
Survival data
Progression free survival and Overall survival in months.
Time frame: 2 years
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