Prospective Pathology Foundation Models

NCT07157618 | Recruiting

• 1 other identifier: NFEC-2025-403
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 2

Brief Summary

Histopathology remains the gold standard for disease diagnosis, yet faces challenges including pathologist shortages and diagnostic model limitations. This underscores the critical need to develop deep learning-based pathology foundation models integrating prospective imaging and clinical data. Such models would enhance diagnostic accuracy and efficiency, enabling tumor grading, histo-molecular classification, and intelligent chemotherapy guidance - ultimately optimizing clinical workflows. However, a critical gap remains: the absence of prospectively validated, pan-disease pathology foundation models. Developing clinically validated models is therefore imperative.

Conditions

Pancancer

Outcome Measures

Primary Outcomes (1)

• Area under ROC curve (AUC)

  Area under the curve

  Diagnostic evaluation will be performed within 1 week when the WSIs are obtained

Secondary Outcomes (2)

• Specificity

  Diagnostic evaluation will be performed within 1 week when the WSIs are obtained

• Sensitivity

  Diagnostic evaluation will be performed within 1 week when the WSIs are obtained

Study Arms (3)

QFSH external validation dataset

1000 slides from 1000 eligible individuals were obtained in the Qianfoshan Hospital (QFSH, Jinan, China) between January 2020 and July 2025, which was used to validate the pathology foundation models.

Prospective validation datasets

We conducted a prospective validation study to compare the diagnostic performance among pathologists, our pathology foundation model, and pathologist-with-AI-assisted diagnosis. This study was initiated on August 28, 2025 at Nanfang Hospital, Southern Medical University, The First Affiliated Hospital, Zhejiang University School of Medicine, The First Affiliated Hospital of Zhengzhou University, Zhujiang Hospital, Southern Medical University, Zhongshan People's Hospital, The First Affiliated Hospital of Shantou University Medical College, and Xijing Hospital, Fourth Military Medical University.

Randomized controlled trial

We conducted a prospective randomized controlled trial to compare the diagnostic performance among pathologists, the pathology foundation model, and pathologist-with-model-assisted diagnosis at Nanfang Hospital of Southern Medical University (NFHSMU).The trial commenced data collection on August 28, 2025 to establish the NFHSMU randomized controlled trial dataset. Following quality control, the slides were randomly allocated (1:1:1 ratio) into three groups:Model-only group/Pathologist-only group/Model-assisted pathologist group.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inclusion criteria comprised patients aged 18-75 years with definitive pathological diagnoses. All cases were prospectively collected from Nanfang Hospital, Southern Medical University (NFHSMU) .

You may qualify if:

• Aged 18-75 years old.
• Patients with complete pathological slides and clinical information.

You may not qualify if:

• Patients with missing data or specimens not meeting quality control requirements for analysis.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Qianfoshan Hospital: collaborator
• Zhejiang University: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• First Affiliated Hospital of Shantou University Medical College: collaborator
• Zhujiang Hospital: collaborator
• Air Force Military Medical University, China: collaborator

Study Sites (2)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Qianfoshan Hospital

Jinan, Shandong, 250014, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples Without DNA: Samples retained, with no potential for DNA extraction from any retained samples (e.g., fixed tissue, plasma)

Study Officials

• Li Liang

  Nanfang Hospital, Southern Medical University

  STUDY DIRECTOR

Central Study Contacts

Zhengyu Zhang

CONTACT

+8613837365993; zzyusmu@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start: August 28, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)