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Recruiting Observational

Survival Analysis in patiEnts With Bad Prognosis Epithelial Ovarian CArcinoma

NCT07540403 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-03-24
Last updated
2026-04-20

Condition(s) studied

Ovarian Cancer

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07540403 on ClinicalTrials.gov ↗ ← All trials in Italy