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临床试验/NCT07057167
NCT07057167尚未招募不适用

Prediction of Ovarian Cancer Histotypes and Surgical Outcome Through Artificial Intelligence

Fondazione Policlinico Universitario Agostino Gemelli IRCCS0 个研究点目标入组 100 人开始时间: 2025年11月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Accuracy of Computer Vision Algorithm in Predicting Ovarian Cancer Histotype

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Accuracy of Computer Vision Algorithm in Predicting Ovarian Cancer Histotype

时间窗: 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.

次要结局

  • Accuracy of Computer Vision Algorithm in Predicting Morphological Classification(36 months)
  • Accuracy of Computer Vision Algorithm in Predicting Molecular and Genetic Tumor Profiles(36 months)
  • Accuracy of Computer Vision Algorithm in Predicting Chemosensitivity or Chemoresistance in High-Grade Serous Ovarian Cancer (HGSOC)(36 months)
  • Accuracy of Computer Vision Algorithm in Predicting the Feasibility of Achieving Complete Gross Resection (CGR)(36 months)

研究者

申办方类型
Other
责任方
Sponsor

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