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NCT Number: NCT07540403

Survival Analysis in patiEnts With Bad Prognosis Epithelial Ovarian CArcinoma

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00136, Italy

Location status: Recruiting

Location contact

Claudia Marchetti

CONTACT

[email protected]

0630156485

Claudia Marchetti

PRINCIPAL_INVESTIGATOR

About this study

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

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.
  • EXCLUSION CRITERIA
  • Age <18 years.
  • Patients with non-epithelial ovarian carcinoma.
  • Patients with a PFS >6 months.

Treatment and study plan

Primary outcomes

  1. Characteristic 1 of patients

    Time frame: 2 years

    Weight (Kg) expressed as mean and standard deviation or median and interquartile range, as appropriate.

  2. Characteristic 2 of patients

    Time frame: 2 years

    Height (cm) expressed as mean and standard deviation or median and interquartile range, as appropriate.

  3. Characteristic 3 of patients

    Time frame: 2 years

    Age (years) expressed as mean and standard deviation or median and interquartile range, as appropriate.

  4. Characteristic 4 of patients

    Time frame: 2 years

    ca 125 levels (U/mL) expressed as mean and standard deviation or median and interquartile range, as appropriate.

  5. Characteristic 5 of patients

    Time frame: 2 years

    Tumor stage (1-2-3-4) expressed as absolute and percentage frequency.

  6. Characteristic 6 of patients

    Time frame: 2 years

    histotype (HGSOC, LGSOC, HG endometrioid, LG endometrioid, clear cell, other) expressed as absolute and percentage frequency.

  7. Characteristic 7 of patients

    Time frame: 2 years

    molecular profiling (HRD positive, HRD negative) expressed as absolute and percentage frequency.

  8. Characteristic 8 of patients

    Time frame: 2 years

    mutation of BRCA ½ (mutation, wild type) expressed as absolute and percentage frequency.

Secondary outcomes

  1. Survival data

    Time frame: 2 years

    Progression free survival and Overall survival in months.

Study contacts

Contact information is provided by the study sponsor or research team.

Claudia Marchetti

CONTACT

[email protected]

00393935860248

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: EPOCA

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 20, 2026
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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