AI prediction of glioma molecular markers from pathology images
A Prospective Real-World Study of Pathology Artificial Intelligence for Predicting Molecular Alterations in Gliomas
This project will test whether an AI model can use routine pathology images to predict key molecular changes in adults with glioma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07263711 on ClinicalTrials.gov |
What this trial studies
Researchers will collect hematoxylin-and-eosin whole-slide pathology images and the corresponding postoperative molecular test results from participating hospitals. An AI model will generate predictions of key glioma molecular alterations from the digital slides. Those AI predictions will be compared directly with standard laboratory molecular testing to measure accuracy and timing. No extra treatments or procedures are required beyond standard clinical care.
Who should consider this trial
Good fit: Adults (age 18 and over) with a histologically suspected diffuse glioma who have usable H&E whole-slide images and available postoperative molecular pathology results are ideal candidates.
Not a fit: Patients under 18, those without postoperative molecular test results, or those with poor-quality or insufficient pathology slides are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the AI tool could provide faster and lower-cost molecular diagnoses to help guide glioma treatment decisions.
How similar studies have performed: Retrospective studies have shown encouraging results for predicting some glioma markers from histology, but prospective real-world validation remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant (or legally authorized representative) has voluntarily signed the informed consent form. * Age ≥ 18 years at the time of enrollment. * Histologically suspected diffuse glioma based on biopsy or surgical resection. * Availability of complete clinical information and usable digital pathology slides with hematoxylin and eosin (H\&E) staining. * Postoperative molecular pathology results available for comparison. Exclusion Criteria: * Poor-quality pathology samples (e.g., insufficient tissue, large folding or contamination of slides, or substandard digital scanning quality). * Determined by the investigator to be unsuitable for participation in the study for any reason.
Where this trial is running
Guangzhou, Guangdong
- Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Danyi Li
- Email: lidanyi26@163.com
- Phone: +8613538308634
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.