Prospective Pathology Foundation Models

NCT ID: NCT07157618

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-28

Study Completion Date

2028-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pancancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Prospective validation dataset

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 (NFHSMU).

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1.Patients with missing data or specimens not meeting quality control requirements for analysis.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qianfoshan Hospital

OTHER

Sponsor Role collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Li Liang

Role: STUDY_DIRECTOR

Nanfang Hospital, Southern Medical University

Locations

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Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Qianfoshan Hospital

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhengyu Zhang

Role: CONTACT

+8613837365993

Facility Contacts

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Li Liang

Role: primary

+8615989146266

Zhengyu Zhang

Role: backup

+8613837365993

Chenglong Zhao

Role: primary

+8615269183992

Other Identifiers

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NFEC-2025-403

Identifier Type: -

Identifier Source: org_study_id

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