Survival Analysis in patiEnts With Bad Prognosis Epithelial Ovarian CArcinoma

NCT07540403 | Recruiting

• 1 other identifier: 6501
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Keywords

ovarian cancer; platinum-resistance; recurrence

Outcome Measures

Primary Outcomes (8)

• Characteristic 1 of patients

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

  2 years

• Characteristic 2 of patients

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

  2 years

• Characteristic 3 of patients

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

  2 years

• Characteristic 4 of patients

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

  2 years

• Characteristic 5 of patients

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

  2 years

• Characteristic 6 of patients

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

  2 years

• Characteristic 7 of patients

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

  2 years

• Characteristic 8 of patients

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

  2 years

Secondary Outcomes (1)

• Survival data

  2 years

Study Arms (1)

platinum-resistant recurrence

All patients will be trated according to standard practice

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: ovarian cancer diagnosis
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with Ovarian Cancer with PFS ≤6 months meeting the inclusion criteria and whose diagnostic-therapeutic pathway took place between January 2017 and December 2023 will be included.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00136, Italy

RECRUITING

Related Publications (3)

• Davis A, Tinker AV, Friedlander M. "Platinum resistant" ovarian cancer: what is it, who to treat and how to measure benefit? Gynecol Oncol. 2014 Jun;133(3):624-31. doi: 10.1016/j.ygyno.2014.02.038. Epub 2014 Mar 4.

  PMID: 24607285 BACKGROUND

• Wilson MK, Pujade-Lauraine E, Aoki D, Mirza MR, Lorusso D, Oza AM, du Bois A, Vergote I, Reuss A, Bacon M, Friedlander M, Gallardo-Rincon D, Joly F, Chang SJ, Ferrero AM, Edmondson RJ, Wimberger P, Maenpaa J, Gaffney D, Zang R, Okamoto A, Stuart G, Ochiai K; participants of the Fifth Ovarian Cancer Consensus Conference. Fifth Ovarian Cancer Consensus Conference of the Gynecologic Cancer InterGroup: recurrent disease. Ann Oncol. 2017 Apr 1;28(4):727-732. doi: 10.1093/annonc/mdw663.

  PMID: 27993805 BACKGROUND

• Pignata S, C Cecere S, Du Bois A, Harter P, Heitz F. Treatment of recurrent ovarian cancer. Ann Oncol. 2017 Nov 1;28(suppl_8):viii51-viii56. doi: 10.1093/annonc/mdx441.

  PMID: 29232464 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

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

Study Officials

• Claudia Marchetti

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia Marchetti

CONTACT

00393935860248; claudia.marchetti@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: April 20, 2026
• Study Start: March 24, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)