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Recruiting NCT07540403

Survival Analysis in patiEnts With Bad Prognosis Epithelial Ovarian CArcinoma

Conditions: Ovarian Cancer

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

trial.available_in: БГ
Overview
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.
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.
Who can participate
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.
Locations 1
Italy (1)
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Female only
Minimum age
18 Years
Healthy volunteers
No
Start date
24.03.2025
Completion date
01.03.2027
Registry ID
NCT07540403
Source
clinicaltrials.gov
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