Ovarian CancerVisual-PCNCT07321730
Surgeons' Ability to Predict Pathological and Molecular Features of Peritoneal Carcinomatosis in Ovarian Cancer
An observational study of Ovarian Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
Epithelial ovarian cancer (EOC) presents with peritoneal carcinomatosis (PC) at diagnosis in approximately two-thirds of cases. Diagnostic laparoscopy is pivotal to assess disease extent and to guide the choice between primary cytoreductive surgery (PCS) and neoadjuvant chemotherapy followed by interval cytoreductive… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- VISUAL PC - SURVEY 2.0
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2026to 30 Jun 2026
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Gynecologic oncologists with surgical experience in the management of ovarian cancer, both senior and young surgeons. A senior surgeon is a reference surgeon with a high level of expertise in ovarian cancer (OC) surgery, typically with years of independent surgical practice or holding a leadership or responsible role. The junior surgeon is a surgeon in advanced training or with a few years of experience in complex oncologic surgery for ovarian cancer.
Who may be able to join
- Gynecologic oncologists involved in the surgical management of ovarian cancer
- Gynecology oncology surgeons with a high level of expertise in OC surgery, with years of independent surgical practice
- Gynecology oncology surgeons holding a leading/responsible position.
- Gynecology oncology surgeons in training in oncologic surgery for ovarian cancer.
- Gynecology oncology surgeons with few years of experience in oncologic surgery for ovarian cancer.
- Patients with advanced OC who underwent diagnostic laparoscopy, with the intra- operative video available as part of routine clinical practice.
- The patient's written informed consent will be required to authorize the use of images extracted from diagnostic laparoscopy videos.
- The informed consent of the participating gynecologic oncologists will be collected electronically through the survey (e.g., via checkbox or digital acceptance).
Who cannot join
- Surgeons not involved in the surgical management of ovarian cancer.
- Incomplete questionnaires or questionnaires not completed according to the provided instructions
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Epithelial ovarian cancer (EOC) presents with peritoneal carcinomatosis (PC) at diagnosis in approximately two-thirds of cases. Diagnostic laparoscopy is pivotal to assess disease extent and to guide the choice between primary cytoreductive surgery (PCS) and neoadjuvant chemotherapy followed by interval cytoreductive surgery (ICS). The Predictive Index Value (PIV) provides a quantitative estimate of resectability, but it does not systematically capture qualitative intraoperative descriptors. Growing evidence suggests that macroscopic features (e.g., nodularity, plaques, omental cake, infiltrative vs expansile growth, margin definition, vascularization, and tissue retraction) may correlate with histotype and molecular profile, and possibly with chemosensitivity. However, surgeons' ability to recognize these visual patterns in a standardized manner has not been systematically investigated.
This cross-sectional survey will assess whether gynecologic oncologic surgeons managing PC can: distinguish malignant metastases from benign tumor-like lesions; associate morphologic patterns with tumor histotypes (type I vs type II EOC and ovarian metastases from other primaries); classify high-grade serous ovarian cancer (HGSOC) growth pattern as infiltrative vs exophytic/expansile; and infer molecular status from macroscopic appearance. The secondary objective is to compare accuracy and confidence between senior and junior surgeons.
Seventy to eighty surgeons will complete an online survey (Microsoft Forms) presenting anonymized laparoscopic images retrospectively selected from routinely recorded diagnostic-laparoscopy videos of 19 consented patients with advanced EOC and PC. Participants will classify each case using predefined categories and rate confidence on a 5-point Likert scale. Analyses will be primarily descriptive (counts/percentages); senior vs junior comparisons will use χ²/Fisher's exact tests for categorical variables and the Mann-Whitney U test for ordinal measures, as appropriate.
- Conditions
- Ovarian Cancer
- Being tested
- VISUAL PC - SURVEY 2.0
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VISUAL PC - SURVEY 2.0Other
Survey for surgeons in order to study their ability to recognize macroscopic features for selecting appropriate treatment strategies in patients with abdominal malignancies.
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual pattern of ovarian cancer
To assess the ability of gynecologic oncologic surgeons to visually recognize pathological and molecular features of peritoneal carcinomatosis in advanced ovarian cancer.
Measured: 1 month
Secondary outcomes (1)
Differences beetween senior and junior surgeons
To compare diagnostic accuracy between senior and junior surgeons.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start10 Jan 2026 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Fagotti, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321730
- Sponsor's protocol ID
- 8151
- Acronym
- Visual-PC
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgeons' Ability to Predict Pathological and Molecular Features of Peritoneal Carcinomatosis in Ovarian Cancer
- ClinicalTrials.gov ID
- NCT07321730
- Acronym / sponsor ID
- Visual-PC / 8151
- Conditions
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 10 Jan 2026 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 7 Jan 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.
Epithelial ovarian cancer (EOC) presents with peritoneal carcinomatosis (PC) at diagnosis in approximately two-thirds of cases. Diagnostic laparoscopy is pivotal to assess disease extent and to guide the choice between primary cytoreductive surgery (PCS) and neoadjuvant chemotherapy followed by interval cytoreductive surgery (ICS). The Predictive Index Value (PIV) provides a quantitative estimate of resectability, but it does not systematically capture qualitative intraoperative descriptors. Growing evidence suggests that macroscopic features (e.g., nodularity, plaques, omental cake, infiltrative vs expansile growth, margin definition, vascularization, and tissue retraction) may correlate with histotype and molecular profile, and possibly with chemosensitivity. However, surgeons' ability to recognize these visual patterns in a standardized manner has not been systematically investigated.
This cross-sectional survey will assess whether gynecologic oncologic surgeons managing PC can: distinguish malignant metastases from benign tumor-like lesions; associate morphologic patterns with tumor histotypes (type I vs type II EOC and ovarian metastases from other primaries); classify high-grade serous ovarian cancer (HGSOC) growth pattern as infiltrative vs exophytic/expansile; and infer molecular status from macroscopic appearance. The secondary objective is to compare accuracy and confidence between senior and junior surgeons.
Seventy to eighty surgeons will complete an online survey (Microsoft Forms) presenting anonymized laparoscopic images retrospectively selected from routinely recorded diagnostic-laparoscopy videos of 19 consented patients with advanced EOC and PC. Participants will classify each case using predefined categories and rate confidence on a 5-point Likert scale. Analyses will be primarily descriptive (counts/percentages); senior vs junior comparisons will use χ²/Fisher's exact tests for categorical variables and the Mann-Whitney U test for ordinal measures, as appropriate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Gynecologic oncologists with surgical experience in the management of ovarian cancer, both senior and young surgeons. A senior surgeon is a reference surgeon with a high level of expertise in ovarian cancer (OC) surgery, typically with years of independent surgical practice or holding a leadership or responsible role. The junior surgeon is a surgeon in advanced training or with a few years of experience in complex oncologic surgery for ovarian cancer.
Key inclusion criteria (8 listed)
- Gynecologic oncologists involved in the surgical management of ovarian cancer
- Gynecology oncology surgeons with a high level of expertise in OC surgery, with years of independent surgical practice
- Gynecology oncology surgeons holding a leading/responsible position.
- Gynecology oncology surgeons in training in oncologic surgery for ovarian cancer.
- Gynecology oncology surgeons with few years of experience in oncologic surgery for ovarian cancer.
Key exclusion criteria (2 listed)
- Surgeons not involved in the surgical management of ovarian cancer.
- Incomplete questionnaires or questionnaires not completed according to the provided instructions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VISUAL PC - SURVEY 2.0Survey for surgeons in order to study their ability to recognize macroscopic features for selecting appropriate treatment strategies in patients with abdominal malignancies. | Other | – |
Primary outcome
Visual pattern of ovarian cancer
Time frame: 1 month
To assess the ability of gynecologic oncologic surgeons to visually recognize pathological and molecular features of peritoneal carcinomatosis in advanced ovarian cancer.
1 secondary outcome
Differences beetween senior and junior surgeons
Time frame: 1 month
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 7 Jan 2026.
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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.
Anna Fagotti principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. 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: opening soon, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Anna Fagotti (+390630153502, anna.fagotti@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual pattern of ovarian cancer (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2026.