Retrospective Pathology Foundation Models

NCT07239297 | Enrolling By Invitation

• 1 other identifier: NFEC-2025-419
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 2

Brief Summary

By integrating retrospective multimodal data such as pathology and imaging, AI technologies offer novel solutions for disease classification, tumor grading, histological and molecular subtyping, selection of chemotherapy regimens, risk stratification, and treatment-response prediction. This research direction not only deepens our understanding of tumor biological characteristics but also provides essential support for precision medicine and individualized therapy. It holds significant theoretical and practical value and has important implications for mitigating strained medical resources and improving the accuracy of therapeutic decision-making, representing a cutting-edge application with substantial translational potential.

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 (2)

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.

NFH dataset

We conducted a validation study to compare the diagnostic performance among pathologists, our pathology foundation model, and pathologist-with-AI-assisted diagnosis. This study was initiated at Nanfang Hospital, Southern Medical University (NFHSMU), with patient enrollment from January 1, 2011 to July 31, 2024.

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 retrospectively 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

Study Sites (2)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Qianfoshan Hospital

Jinan, Shandong, 250014, China

Location

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

Study Design

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

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)