Development and Validation of an AI Foundation Model for Frozen-Section Pathology (NCT07708207) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Development and Validation of an AI Foundation Model for Frozen-Section Pathology
China33,000 participantsStarted 2026-04-27
Plain-language summary
This multicenter observational study aims to develop and validate an artificial intelligence foundation model for frozen-section pathology.
The study includes a retrospective phase and a prospective validation phase. Retrospective frozen-section pathology data will be used for model development, internal validation, and external validation. A prospective multicenter cohort of patients undergoing intraoperative frozen-section examination will then be enrolled to evaluate the model in a real-world clinical setting.
The model will analyze digitized frozen-section whole-slide images and will be evaluated for prespecified frozen-section pathology diagnostic tasks across multiple organ systems. Its performance will be assessed using pathological reference standards. The primary outcome is the area under the receiver operating characteristic curve. Secondary outcomes include accuracy, sensitivity, specificity, positive predictive value, and negative predictive value.
This study is observational and will not require research-mandated changes to routine clinical care.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients undergoing surgery with intraoperative frozen-section pathological examination.
* Availability of complete clinical information and intraoperative frozen-section pathology records.
* Availability of digitized frozen-section whole-slide images suitable for artificial intelligence analysis.
Exclusion Criteria:
* Frozen-section whole-slide images with inadequate quality for evaluation, including substantial blur, ghosting, severe artifacts, or insufficient diagnostic tissue.
* Missing or indeterminate key clinical, intraoperative pathology, or pathological reference data required for the prespecified study task.
* Withdrawal of informed consent in the prospective validation cohort, where applicable.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area Under the Receiver Operating Characteristic Curve
Timeframe: For each enrolled patient, the diagnosis results of AI model will be obtained in several days after intraoperative pathology completion, and the AUROC of the AI model will be evaluated through study completion, an average of 3 year.
Trial details
NCT IDNCT07708207
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University