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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| platinum-resistant recurrence | All patients will be trated according to standard practice |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Survival data | Progression free survival and Overall survival in months. | 2 years |
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INCLUSION CRITERIA
EXCLUSION CRITERIA
ovarian cancer diagnosis
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claudia Marchetti | Contact | 00393935860248 | claudia.marchetti@policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Claudia Marchetti | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | Rome | 00136 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24607285 | Background | 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. | |
| 27993805 | 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. |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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mutation of BRCA ½ (mutation, wild type) expressed as absolute and percentage frequency. |
| 2 years |
| 29232464 | 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. |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |