Ovarian CancerPANtHer-AINCT07057167
Prediction of Ovarian Cancer Histotypes and Surgical Outcome
An observational study of Ovarian Cancer and Metastatic Ovarian Carcinoma, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
The standard treatment for advanced ovarian cancer (AOC) is primary cytoreductive surgery (PCS) followed by adjuvant chemotherapy. However, optimal cytoreduction is not always achievable, particularly in cases with high tumor burden or patient frailty. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Metastatic Ovarian Carcinoma
- What is being tested?
- Diagnostic Laparoscopy videos
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2025to 10 Oct 2027
- 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: Patients with advanced ovarian cancer who underwent diagnostic laparoscopy at the time of diagnosis, with or without subsequent cytoreductive surgery.
Who may be able to join
- Patients over 18 years of age
- Patients fit for upfront cytoreductive surgery.
- Patients undergoing diagnostic laparoscopy as part of the upfront decision-making algorithm.
- Patients with a primary diagnosis of advanced ovarian carcinoma, FIGO stage IIIB - IVB
- Signature of the informed consent / consent for the processing of personal data and associated data for research purposes in patients treated at the Fondazione Policlinico Universitario A. Gemelli IRCCS (form 743 or form pro.1145.001) / substitute declaration for the consent form for deceased patients.
Who cannot join
- Lack of information on surgical outcome and clinical-pathological characteristics.
- Ovarian carcinoma patients without evidence of macroscopic peritoneal carcinomatosis (FIGO stage I-IIIA).
- Secondary cytoreductive surgery.
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
Official title: Prediction of Ovarian Cancer Histotypes and Surgical Outcome Through Artificial Intelligence
The standard treatment for advanced ovarian cancer (AOC) is primary cytoreductive surgery (PCS) followed by adjuvant chemotherapy. However, optimal cytoreduction is not always achievable, particularly in cases with high tumor burden or patient frailty. In such scenarios, neoadjuvant chemotherapy (NACT) followed by interval cytoreductive surgery (ICS) represents a valid alternative with comparable oncologic outcomes in selected patients.
To optimize surgical strategy, objective tools are needed to identify the best candidates for PCS. Scoring systems such as the Fagotti Score and the Predictive Index Value (PIV) assess tumor resectability, but their accuracy largely depends on surgeon expertise.
Read more
It has already developed the PREDAtOOR project, a significant advancement in the use of artificial intelligence (AI) for managing AOC. PREDAtOOR has demonstrated high accuracy in both predicting the Fagotti Score and segmenting lesions from diagnostic laparoscopy videos, thus supporting a more objective and reproducible surgical decision-making process.
Importantly, therapeutic strategies should also consider tumor biology, as the response to NACT varies across histological and molecular subtypes. Unfortunately, such information is usually derived from histopathological and genomic analyses performed only after the surgical decision.
Kurman and Shih proposed a dualistic model of epithelial ovarian tumors, with distinct clinical and molecular features:
Type I tumors (low-grade serous, endometrioid, clear cell, mucinous): indolent growth, typically confined to the ovary, with stable genomes. Early-stage cases may be cured surgically. Metastatic Type I tumors tend to be chemoresistant but may respond to targeted therapies.
Type II tumors (high-grade serous carcinoma [HGSC], carcinosarcomas, undifferentiated carcinomas): aggressive behavior, marked genomic instability, and frequent homologous recombination deficiency (HRD). Although initially sensitive to platinum-based chemotherapy and PARP inhibitors, resistance often emerges.
Among these, HGSC is the most frequent and lethal. Yet, even within HGSC, substantial variability in chemotherapy response and clinical outcome is observed. A recent morphologic classification of HGSC stratifies tumors into infiltrative vs. expansive patterns, associated with specific molecular alterations and therapeutic responses.
However, these morphological and molecular features are not yet integrated into intraoperative decision-making, highlighting a need for new intraoperative tools to personalize care.
In this precision medicine landscape, AI, particularly through machine learning and computer vision, offers powerful solutions. These technologies can process large, heterogeneous datasets and automate intraoperative assessments, enhancing objectivity and diagnostic reproducibility. While AI-based classification of histologic and molecular subtypes from laparoscopy remains largely unexplored, it holds the potential to revolutionize treatment stratification in AOC.
- Conditions
- Ovarian Cancer, Metastatic Ovarian Carcinoma
- Being tested
- Diagnostic Laparoscopy videos
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Laparoscopy videosOther
Diagnostic laparoscopy videos will be collected and stored on internal hard drives.
Pseudo-anonymized laparoscopic videos will be annotated by expert clinicians. Artificial intelligence (AI)-based solutions will be developed, trained, and validated.
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Computer Vision Algorithm in Predicting Ovarian Cancer Histotype
Proportion (%) of laparoscopic videos in which the computer vision algorithm correctly predicts the histotype of ovarian cancer (Non-Epithelial vs Epithelial, and Epithelial subtypes: Type I vs Type II), using final histopathological diagnosis as the reference standard.
Measured: 36 months
Secondary outcomes (4)
Accuracy of Computer Vision Algorithm in Predicting Morphological Classification
Proportion (%) of laparoscopic videos of high-grade serous ovarian cancer (HGSOC) in which the computer vision algorithm correctly classifies the tumor into two distinct morphological subtypes (as defined by Handley et al.) during diagnostic laparoscopy, using expert pathological assessment as the reference standard.
Measured: 36 months
Accuracy of Computer Vision Algorithm in Predicting Molecular and Genetic Tumor Profiles
Proportion (%) of laparoscopic videos in which the computer vision algorithm correctly predicts molecular and genetic tumor profiles (homologous recombination deficiency [HRD] status, homologous recombination proficiency [HRP] status, and BRCA mutation status) using molecular/genetic testing as the reference standard.
Measured: 36 months
Accuracy of Computer Vision Algorithm in Predicting Chemosensitivity or Chemoresistance in High-Grade Serous Ovarian Cancer (HGSOC)
Proportion (%) of laparoscopic videos of high-grade serous ovarian cancer (HGSOC) in which the computer vision algorithm correctly predicts chemosensitivity (platinum-free interval [PFI] > 6 months) or chemoresistance (PFI < 6 months), using clinical follow-up as the reference standard.
Measured: 36 months
Accuracy of Computer Vision Algorithm in Predicting the Feasibility of Achieving Complete Gross Resection (CGR)
Proportion (%) of laparoscopic videos in which the computer vision algorithm correctly predicts the feasibility of achieving complete gross resection (CGR; defined as no visible residual disease at the end of surgery), compared with the actual surgical outcome documented by surgical reports
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start10 Nov 2025 (estimated)
- Primary completion10 Oct 2026 (estimated)
- Study completion10 Oct 2027 (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
- Retrospective
- Enrolment
- 100 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
- NCT07057167
- Sponsor's protocol ID
- 7504
- Acronym
- PANtHer-AI
- Status last verified
- Jun 2025
- First submitted
- 27 Jun 2025
- Last updated
- 20 Nov 2025
- 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 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Ovarian Cancer Histotypes and Surgical Outcome Through Artificial Intelligence
- ClinicalTrials.gov ID
- NCT07057167
- Acronym / sponsor ID
- PANtHer-AI / 7504
- Conditions
- Ovarian Cancer, Metastatic Ovarian Carcinoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 10 Nov 2025 (estimated)
- Primary completion
- 10 Oct 2026 (estimated)
- Study completion
- 10 Oct 2027 (estimated)
- First posted
- 9 Jul 2025 (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.
The standard treatment for advanced ovarian cancer (AOC) is primary cytoreductive surgery (PCS) followed by adjuvant chemotherapy. However, optimal cytoreduction is not always achievable, particularly in cases with high tumor burden or patient frailty. In such scenarios, neoadjuvant chemotherapy (NACT) followed by interval cytoreductive surgery (ICS) represents a valid alternative with comparable oncologic outcomes in selected patients.
To optimize surgical strategy, objective tools are needed to identify the best candidates for PCS. Scoring systems such as the Fagotti Score and the Predictive Index Value (PIV) assess tumor resectability, but their accuracy largely depends on surgeon expertise.
It has already developed the PREDAtOOR project, a significant advancement in the use of artificial intelligence (AI) for managing AOC. PREDAtOOR has demonstrated high accuracy in both predicting the Fagotti Score and segmenting lesions from diagnostic laparoscopy videos, thus supporting a more objective and reproducible surgical decision-making process.
Importantly, therapeutic strategies should also consider tumor biology, as the response to NACT varies across histological and molecular subtypes. Unfortunately, such information is usually derived from histopathological and genomic analyses performed only after the surgical decision.
Kurman and Shih proposed a dualistic model of epithelial ovarian tumors, with distinct clinical and molecular features:
Type I tumors (low-grade serous, endometrioid, clear cell, mucinous): indolent growth, typically confined to the ovary, with stable genomes. Early-stage cases may be cured surgically. Metastatic Type I tumors tend to be chemoresistant but may respond to targeted therapies.
Type II tumors (high-grade serous carcinoma [HGSC], carcinosarcomas, undifferentiated carcinomas): aggressive behavior, marked genomic instability, and frequent homologous recombination deficiency (HRD). Although initially sensitive to platinum-based chemotherapy and PARP inhibitors, resistance often emerges.
Among these, HGSC is the most frequent and lethal. Yet, even within HGSC, substantial variability in chemotherapy response and clinical outcome is observed. A recent morphologic classification of HGSC stratifies tumors into infiltrative vs. expansive patterns, associated with specific molecular alterations and therapeutic responses.
However, these morphological and molecular features are not yet integrated into intraoperative decision-making, highlighting a need for new intraoperative tools to personalize care.
In this precision medicine landscape, AI, particularly through machine learning and computer vision, offers powerful solutions. These technologies can process large, heterogeneous datasets and automate intraoperative assessments, enhancing objectivity and diagnostic reproducibility. While AI-based classification of histologic and molecular subtypes from laparoscopy remains largely unexplored, it holds the potential to revolutionize treatment stratification in AOC.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced ovarian cancer who underwent diagnostic laparoscopy at the time of diagnosis, with or without subsequent cytoreductive surgery.
Key inclusion criteria (5 listed)
- Patients over 18 years of age
- Patients fit for upfront cytoreductive surgery.
- Patients undergoing diagnostic laparoscopy as part of the upfront decision-making algorithm.
- Patients with a primary diagnosis of advanced ovarian carcinoma, FIGO stage IIIB - IVB
- Signature of the informed consent / consent for the processing of personal data and associated data for research purposes in patients treated at the Fondazione Policlinico Universitario A. Gemelli IRCCS (form 743 or form pro.1145.001) / substitute declaration for the consent form for deceased patients.
Key exclusion criteria (3 listed)
- Lack of information on surgical outcome and clinical-pathological characteristics.
- Ovarian carcinoma patients without evidence of macroscopic peritoneal carcinomatosis (FIGO stage I-IIIA).
- Secondary cytoreductive surgery.
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 |
|---|---|---|
| Diagnostic Laparoscopy videosDiagnostic laparoscopy videos will be collected and stored on internal hard drives. Pseudo-anonymized laparoscopic videos will be annotated by expert clinicians. Artificial intelligence (AI)-based solutions will be developed, trained, and validated. | Other | – |
Primary outcome
Accuracy of Computer Vision Algorithm in Predicting Ovarian Cancer Histotype
Time frame: 36 months
Proportion (%) of laparoscopic videos in which the computer vision algorithm correctly predicts the histotype of ovarian cancer (Non-Epithelial vs Epithelial, and Epithelial subtypes: Type I vs Type II), using final histopathological diagnosis as the reference standard.
4 secondary outcomes
Accuracy of Computer Vision Algorithm in Predicting Morphological Classification
Time frame: 36 months
Accuracy of Computer Vision Algorithm in Predicting Molecular and Genetic Tumor Profiles
Time frame: 36 months
Accuracy of Computer Vision Algorithm in Predicting Chemosensitivity or Chemoresistance in High-Grade Serous Ovarian Cancer (HGSOC)
Time frame: 36 months
Accuracy of Computer Vision Algorithm in Predicting the Feasibility of Achieving Complete Gross Resection (CGR)
Time frame: 36 months
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 Nov 2025.
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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 and Metastatic Ovarian Carcinoma, 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 5 inclusion and 3 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 20 Nov 2025. 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 (+390630157004, anna.fagotti@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Computer Vision Algorithm in Predicting Ovarian Cancer Histotype (time frame: 36 months). 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 20 Nov 2025.