Prospective Real-World Study of Pathology AI for Glioma Molecular Prediction

Sponsor
Nanfang Hospital, Southern Medical University
Study ID
NCT07263711
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Study Details

The goal of this clinical study is to learn if an artificial intelligence (AI) model can accurately predict important molecular changes in gliomas, a type of brain tumor, using digital pathology images. The main questions this study aims to answer are: How accurate is the AI model in predicting key molecular alterations compared with standard molecular testing? Can the AI model shorten the time needed for diagnosis and reduce the need for expensive molecular tests? Researchers will collect whole slide images from multiple hospitals and use the AI model to predict molecular results. The predictions will be compared with the actual test results from standard laboratory methods. Participants will: Allow the use of their pathology images and molecular test results for research. Have no additional treatments or procedures beyond standard medical care. This study will help determine whether AI-assisted tools can provide faster and lower-cost molecular diagnosis for glioma, improving patient care and supporting equal access to precision medicine.

Key Dates

First listed
Dec 4, 2025
Start date
Sep 1, 2025
Status verified
Nov 2025
Primary completion
Sep 1, 2030
Completion
Sep 1, 2030

Study Design

Enrollment
2,000 participants (estimated)

Primary Outcome Measure

Accuracy of AI model in predicting key molecular alterations in glioma [ Time Frame: Within 1 week after whole slide images (WSIs) are obtained ]

Central Contacts

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