Survival Analysis in patiEnts With Bad Prognosis Epithelial Ovarian CArcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Ovarian Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
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.
Primary outcome measures
- Characteristic 1 of patients [Time frame: 2 years]
- Characteristic 2 of patients [Time frame: 2 years]
- Characteristic 3 of patients [Time frame: 2 years]
- Characteristic 4 of patients [Time frame: 2 years]
- Characteristic 5 of patients [Time frame: 2 years]
- Characteristic 6 of patients [Time frame: 2 years]
- Characteristic 7 of patients [Time frame: 2 years]
- Characteristic 8 of patients [Time frame: 2 years]
Secondary outcome measures (1)
- Survival data [Time frame: 2 years]
Eligibility criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome
Publications
- 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
- 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 PMID 27993805
- 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
Identifiers
NCT: NCT07540403 · 6501