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Establishment and Clinical Application of AI-based Multimodal Diagnosis System for Ovarian Tumors

NCT06703112 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 584

Last updated 2024-11-25

No results posted yet for this study

Summary

Ovarian tumors are a common disease that threatens women's health. They are insidious in onset, have over ten pathological types, and exhibit diverse biological behaviors, making accurate diagnosis a key factor in clinical decision-making and improving prognosis. Introducing AI technology to establish an auxiliary diagnosis system composed of multi-dimensional clinical data, including medical imaging and tumor markers, will greatly enhance diagnosis efficiency by predicting the pathological types of common ovarian tumors.

Our research group has innovatively developed an AI-based ultrasound intelligent auxiliary diagnosis software for ovarian tumors, which has been clinically validated to be effective. This project will build on this by: (1) utilizing a wealth of multi-center retrospective clinical data to combine ultrasound, MRI images, physiological, pathological, and laboratory data to form the first multi-modal ovarian tumor public dataset supporting AI tasks; (2) using convolutional neural network technology to realize multi-modal image multi-classification intelligent recognition on this dataset based on surgical pathology as the standard, and then fuse features at the level of clinical data with the intelligent recognition model to train and validate an auxiliary diagnosis model for predicting the top ten pathological types of ovarian tumors; (3) applying privacy computing and federated learning methods to conduct multi-center, prospective validation and optimization of the above model, ultimately forming a clinical auxiliary diagnosis system that can predict the pathological types of most ovarian tumors and apply it to clinical practice.

Conditions

  • Ovarian Tumors

Interventions

DIAGNOSTIC_TEST

An auxiliary diagnostic model for ovarian tumors

Through collaboration among gynecological oncology teams from three research centers, the multimodal ovarian tumor auxiliary diagnosis system will undergo multicenter, prospective clinical application, with surgical pathology results used as the gold standard. The diagnostic performance of the multimodal ovarian tumor auxiliary diagnosis system, both overall and across different pathological categories, will be evaluated in the main and subsidiary centers by comparing metrics such as specificity, sensitivity, positive predictive value, negative predictive value, and area under the ROC curve (AUC).

Sponsors & Collaborators

  • Beijing Friendship Hospital

    collaborator OTHER

  • Beijing Obstetrics and Gynecology Hospital

    collaborator OTHER

  • Beijing Shijitan Hospital, Capital Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2026-12-31
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06703112 on ClinicalTrials.gov