Ovarian Cancer, Recurrent Ovarian Cancer
Conditions
Brief summary
This monocentric observational pilot study aims to assess the feasibility of a standardized two-dimensional ultrasound (2D US) approach for the preoperative assessment and anatomo-surgical classification of liver-area involvement in women with advanced or recurrent epithelial ovarian cancer. The study will evaluate whether standardized ultrasound acquisition and reporting can identify the main patterns of liver-area disease and assign them to predefined surgical classes. In patients with parenchymal lesions, the study will also explore the ability of ultrasound to differentiate liver peritoneal infiltration from hematogenous hepatic metastases. Clinical, ultrasound, surgical, and histological data will be collected from a retrospective and prospective cohort. Ultrasound findings will be compared with surgical findings, with histology used as an additional reference standard when available. The study will also develop a standardized ultrasound acquisition protocol and reporting template to improve reproducibility and support preoperative surgical planning.
Interventions
None listed
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women aged ≥18 years. * Suspicious or histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. * Suspicious primary FIGO stage III-IV disease or recurrent ovarian cancer undergoing complete cytoreductive surgery. * For participants included in the prospective cohort, written informed consent for study participation and processing of personal data. * For the retrospective cohort, eligible participants may include individuals for whom informed consent cannot be obtained because they are deceased or cannot be contacted despite all reasonable efforts to trace them. Data processing will be conducted in accordance with applicable Italian data protection regulations.
Exclusion criteria
\- Previous radiotherapy involving the hepatic area
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of standardized 2D ultrasound for liver-area anatomo-surgical classification | At baseline, before surgery | Proportion of enrolled patients with a complete and evaluable preoperative 2D ultrasound dataset allowing assignment of the anatomo-surgical class of liver-area involvement and, when parenchymal lesions are present, differentiation between liver peritoneal infiltration (LPI) and hematogenous hepatic metastases (HHM). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to the standardized 2D ultrasound acquisition protocol | At baseline, before surgery | Proportion of ultrasound examinations meeting all predefined mandatory views, measurements, and technical settings according to the standardized acquisition protocol. |
| Concordance between ultrasound findings and the anatomo-surgical classification | At surgery | Qualitative comparison between the ultrasound-based classification of liver-area involvement and the anatomo-surgical classification determined from surgical findings, with histological findings used as an additional reference standard when available. |
Countries
Italy
Contacts
CONTACTAntonia Carla Testa
PRINCIPAL_INVESTIGATORAntonia Carla Testa
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Outcome results
None listed