Ovarian CancerEPOCANCT07540403
Survival Analysis in patiEnts With Bad Prognosis Epithelial Ovarian CArcinoma
An observational study of Ovarian Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 24 Mar 2025to 1 Mar 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00136
Claudia Marchetti, 0630156485, claudia.marchetti@policlinicogemelli.it
Claudia Marchetti
About this study
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.
Read the 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.
- Conditions
- Ovarian Cancer
- Keywords
- ovarian cancer, platinum-resistance, recurrence
- Medical subject headings
- Ovarian Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| platinum-resistant recurrence | All patients will be trated according to standard practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristic 1 of patients
Weight (Kg) expressed as mean and standard deviation or median and interquartile range, as appropriate.
Measured: 2 years
Characteristic 2 of patients
Height (cm) expressed as mean and standard deviation or median and interquartile range, as appropriate.
Measured: 2 years
Characteristic 3 of patients
Age (years) expressed as mean and standard deviation or median and interquartile range, as appropriate.
Measured: 2 years
Characteristic 4 of patients
ca 125 levels (U/mL) expressed as mean and standard deviation or median and interquartile range, as appropriate.
Measured: 2 years
Characteristic 5 of patients
Tumor stage (1-2-3-4) expressed as absolute and percentage frequency.
Measured: 2 years
Characteristic 6 of patients
histotype (HGSOC, LGSOC, HG endometrioid, LG endometrioid, clear cell, other) expressed as absolute and percentage frequency.
Measured: 2 years
Characteristic 7 of patients
molecular profiling (HRD positive, HRD negative) expressed as absolute and percentage frequency.
Measured: 2 years
Characteristic 8 of patients
mutation of BRCA ½ (mutation, wild type) expressed as absolute and percentage frequency.
Measured: 2 years
Secondary outcomes (1)
Survival data
Progression free survival and Overall survival in months.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start24 Mar 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARCHETTI CLAUDIA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Claudia Marchetti, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540403
- Sponsor's protocol ID
- 6501
- Acronym
- EPOCA
- Status last verified
- Apr 2026
- First submitted
- 13 Mar 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 24607285Wilson 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.
PubMed 27993805Pignata 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.
PubMed 29232464
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival Analysis in patiEnts With Bad Prognosis Epithelial Ovarian CArcinoma
- ClinicalTrials.gov ID
- NCT07540403
- Acronym / sponsor ID
- EPOCA / 6501
- Conditions
- Ovarian Cancer
- Keywords
- ovarian cancer, platinum-resistance, recurrence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| platinum-resistant recurrence | – | –All patients will be trated according to standard practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characteristic 1 of patients
Time frame: 2 years
Weight (Kg) expressed as mean and standard deviation or median and interquartile range, as appropriate.
Characteristic 2 of patients
Time frame: 2 years
Height (cm) expressed as mean and standard deviation or median and interquartile range, as appropriate.
Characteristic 3 of patients
Time frame: 2 years
Age (years) expressed as mean and standard deviation or median and interquartile range, as appropriate.
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.
Characteristic 5 of patients
Time frame: 2 years
Tumor stage (1-2-3-4) expressed as absolute and percentage frequency.
Characteristic 6 of patients
Time frame: 2 years
histotype (HGSOC, LGSOC, HG endometrioid, LG endometrioid, clear cell, other) expressed as absolute and percentage frequency.
Characteristic 7 of patients
Time frame: 2 years
molecular profiling (HRD positive, HRD negative) expressed as absolute and percentage frequency.
Characteristic 8 of patients
Time frame: 2 years
mutation of BRCA ½ (mutation, wild type) expressed as absolute and percentage frequency.
1 secondary outcome
Survival data
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Background: PubMed 24607285Davis 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.
- Background: PubMed 27993805Wilson 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.
- Background: PubMed 29232464Pignata 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claudia Marchetti principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudia Marchetti (00393935860248, claudia.marchetti@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characteristic 1 of patients (time frame: 2 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07540403, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.