Pathology Foundation ModelNCT07408167
AI Models in Clinical Pathology Diagnosis: A Multicenter RCT
A study testing AI model in people with Pathology Foundation Model, run by Nanfang Hospital, Southern Medical University at 3 sites in China.
Trial summary
The investigators plan to conduct a multicenter, prospective, randomized controlled trial to systematically evaluate the incremental value of pathology-based artificial intelligence (AI) models in a pan-disease diagnostic workflow. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Pathology Foundation Model
- What is being tested?
- AI model
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,060 participants
- Where
- 3 sitesChina
- Study dates
- 1 Mar 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntarily provide written informed consent.
- Age ≥ 20 years.
- Have completed at least 1 year of training in pathological diagnosis.
- Voluntarily provide written informed consent.
- Age ≥ 18 years.
- Have available digital pathology images and relevant clinical information.
Who cannot join
- Individuals with reading difficulties or a reading disorder.
- Unwilling to participate in this study.
- Patients:
- Missing data or data quality not meeting the requirements for analysis.
- Deemed unsuitable for participation by the investigator.
- Unwilling to participate in this study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
The First Hospital Affiliated to AMU SOUTHWEST HOSPITAL
Chongqing, Chongqing Municipality
Xiaohong Yao, 17720466296, yxh15@163.com
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China 510515
Li Liang, +8615989146266, lli@smu.edu.cn
Zhengyu Zhang, zzyusmu@163.com
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Shenglei Li, 13598423254, 13598423254@126.com
About this study
Official title: Performance of AI Models in the Clinical Pathology Diagnostic Workflow: A Multicenter, Prospective, Randomized Controlled Trial
The investigators plan to conduct a multicenter, prospective, randomized controlled trial to systematically evaluate the incremental value of pathology-based artificial intelligence (AI) models in a pan-disease diagnostic workflow. The study will primarily compare interpretation using an AI-assisted platform with conventional independent slide reading in terms of diagnostic accuracy (e.g., AUC), reading efficiency (e.g., diagnostic time), diagnostic report quality, diagnostic confidence (Likert scale), and pathologists' satisfaction with the AI model. Investigators will also assess superiority among less experienced (junior) pathologists and non-inferiority among more experienced (senior) pathologists. Successful completion of this project will provide high-level prospective evidence to support standardized deployment, quality control, and broader implementation of pathology AI in clinical practice. This trial may also evaluate the potential benefits and risks of using AI tools in medical research.
Read the detailed description
In this study, investigators plan to enroll 60 pathologists with varying levels of experience and 2,000 patients requiring pathological diagnosis, with whole-slide images (WSIs) collected.
- Conditions
- Pathology Foundation Model
- Being tested
- AI model, Control
- Keywords
- Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI modelOther
Doctors in this group are required to use the AI model to assist their diagnoses. The AI pathology model will provide a predicted result for each case.
ControlOther
Pathologists will independently diagnose each case based on their own clinical experience, and will record both their time to diagnosis and their diagnostic confidence.
| Study group | Role | What they receive |
|---|---|---|
| AI-assisted group | Experimental | Pathologists in this group are required to use the AI pathology diagnostic model to assist their diagnoses. The AI pathology model will provide a predicted result for each case. Receives: Other: AI model |
| Independent Diagnosis Group (Control Group) | Placebo comparator | In this group, pathologists will independently diagnose each case based on their own clinical experience, and will record both their time to diagnosis and their diagnostic confidence. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under ROC curve (AUC)
Area under the curve
Measured: Assessments will be conducted within one week after the pathologists' diagnoses
Secondary outcomes (2)
Diagnostic time per case
Time required for the pathologist to complete the diagnosis of each case in the AI-assisted diagnosis group compared with the independent diagnosis group. Diagnostic time is defined as the duration (in minutes/seconds) from initiating case review to finalizing and submitting the diagnostic report in the study system.
Measured: Measured immediately after the pathologists' diagnosis
Pathologists' diagnostic confidence
Self-reported diagnostic confidence of pathologists for each case in the AI-assisted diagnosis group compared with the independent diagnosis group. Diagnostic confidence will be rated by the reporting pathologist on a [10]-point Likert scale (e.g., 1 = very uncertain to 10 = very confident) immediately after completing the diagnosis. Higher scores indicate greater diagnostic confidence.
Measured: At the time of diagnosis for each case.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathology Foundation ModelStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,060 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Liang, Study chair, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07408167
- Sponsor's protocol ID
- NFEC-2026-059
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of AI Models in the Clinical Pathology Diagnostic Workflow: A Multicenter, Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07408167
- Acronym / sponsor ID
- NFEC-2026-059
- Conditions
- Pathology Foundation Model
- Keywords
- Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,060 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators plan to conduct a multicenter, prospective, randomized controlled trial to systematically evaluate the incremental value of pathology-based artificial intelligence (AI) models in a pan-disease diagnostic workflow. The study will primarily compare interpretation using an AI-assisted platform with conventional independent slide reading in terms of diagnostic accuracy (e.g., AUC), reading efficiency (e.g., diagnostic time), diagnostic report quality, diagnostic confidence (Likert scale), and pathologists' satisfaction with the AI model. Investigators will also assess superiority among less experienced (junior) pathologists and non-inferiority among more experienced (senior) pathologists. Successful completion of this project will provide high-level prospective evidence to support standardized deployment, quality control, and broader implementation of pathology AI in clinical practice. This trial may also evaluate the potential benefits and risks of using AI tools in medical research.
Detailed description
In this study, investigators plan to enroll 60 pathologists with varying levels of experience and 2,000 patients requiring pathological diagnosis, with whole-slide images (WSIs) collected.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-assisted group | Experimental | Other: AI modelPathologists in this group are required to use the AI pathology diagnostic model to assist their diagnoses. The AI pathology model will provide a predicted result for each case. |
| Independent Diagnosis Group (Control Group) | Placebo comparator | Other: ControlIn this group, pathologists will independently diagnose each case based on their own clinical experience, and will record both their time to diagnosis and their diagnostic confidence. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntarily provide written informed consent.
- Age ≥ 20 years.
- Have completed at least 1 year of training in pathological diagnosis.
- Voluntarily provide written informed consent.
- Age ≥ 18 years.
Key exclusion criteria (6 listed)
- Individuals with reading difficulties or a reading disorder.
- Unwilling to participate in this study.
- Missing data or data quality not meeting the requirements for analysis.
- Deemed unsuitable for participation by the investigator.
- Unwilling to participate in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI modelDoctors in this group are required to use the AI model to assist their diagnoses. The AI pathology model will provide a predicted result for each case. | Other | AI-assisted group |
| ControlPathologists will independently diagnose each case based on their own clinical experience, and will record both their time to diagnosis and their diagnostic confidence. | Other | Independent Diagnosis Group (Control Group) |
Primary outcome
Area under ROC curve (AUC)
Time frame: Assessments will be conducted within one week after the pathologists' diagnoses
Area under the curve
2 secondary outcomes
Diagnostic time per case
Time frame: Measured immediately after the pathologists' diagnosis
Pathologists' diagnostic confidence
Time frame: At the time of diagnosis for each case.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li Liang study chair
Nanfang Hospital, Southern Medical University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI model in people with Pathology Foundation Model, run by Nanfang Hospital, Southern Medical University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhengyu Zhang (13837365993, zzyusmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under ROC curve (AUC) (time frame: Assessments will be conducted within one week after the pathologists' diagnoses). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.