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Not yet recruitingNCT07057167PANtHer-AIUpdated Nov 20, 2025

Prediction of Ovarian Cancer Histotypes and Surgical Outcome

An observational study in Ovarian Cancer and Metastatic Ovarian Carcinoma, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-20.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
Ages
18 Years and older
Sex
Female
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Study 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. 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.

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Conditions studied

  • Ovarian Cancer
  • Metastatic Ovarian Carcinoma

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In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's planned enrollment of 100 is below the median of 200 across 527 observational studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with advanced ovarian cancer who underwent diagnostic laparoscopy at the time of diagnosis, with or without subsequent cytoreductive surgery.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion criteria:

  • 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.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • OtherDiagnostic Laparoscopy videos

    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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 36 months

Secondary outcomes

  1. 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.

    Time frame: 36 months

  2. 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.

    Time frame: 36 months

  3. 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.

    Time frame: 36 months

  4. 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

    Time frame: 36 months

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07057167
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
Sponsor
First posted
Jul 9, 2025
Start date
Nov 10, 2025 (estimated)
Primary completion
Oct 10, 2026 (estimated)
Completion
Oct 10, 2027 (estimated)
Last update
Nov 20, 2025

Study contacts

Anna Fagotti
Contact
anna.fagotti@policlinicogemelli.it
+390630157004
Anna Fagotti
principal investigator · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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