Ovarian Cancer
Conditions
Keywords
ovarian cancer, platinum-resistance, recurrence
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. INCLUSION CRITERIA * Patients diagnosed with histologically confirmed epithelial ovarian carcinoma, fallopian tube carcinoma, or primary peritoneal carcinoma with a PFS ≤6 months. * Age ≥18 years. * Any FIGO (Federation of Gynecology and Obstetrics) stage at diagnosis. * Signed informed consent for the use of personal data for research purposes. * ECOG performance status ≤2. 2.
Exclusion criteria
* Age \<18 years. * Patients with non-epithelial ovarian carcinoma. * Patients with a PFS \>6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characteristic 1 of patients | 2 years | Weight (Kg) expressed as mean and standard deviation or median and interquartile range, as appropriate. |
| Characteristic 2 of patients | 2 years | Height (cm) expressed as mean and standard deviation or median and interquartile range, as appropriate. |
| Characteristic 3 of patients | 2 years | Age (years) expressed as mean and standard deviation or median and interquartile range, as appropriate. |
| Characteristic 4 of patients | 2 years | ca 125 levels (U/mL) expressed as mean and standard deviation or median and interquartile range, as appropriate. |
| Characteristic 5 of patients | 2 years | Tumor stage (1-2-3-4) expressed as absolute and percentage frequency. |
| Characteristic 6 of patients | 2 years | histotype (HGSOC, LGSOC, HG endometrioid, LG endometrioid, clear cell, other) expressed as absolute and percentage frequency. |
| Characteristic 7 of patients | 2 years | molecular profiling (HRD positive, HRD negative) expressed as absolute and percentage frequency. |
| Characteristic 8 of patients | 2 years | mutation of BRCA ½ (mutation, wild type) expressed as absolute and percentage frequency. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival data | 2 years | Progression free survival and Overall survival in months. |
Countries
Italy
Contacts
CONTACTClaudia Marchetti
PRINCIPAL_INVESTIGATORClaudia Marchetti
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Outcome results
None listed