Prospective Real-World Study of Multimodal AI

Prospective Real-World Study of a Multimodal Artificial Intelligence Model Across Disease Types

This project proposes to collect prospective multimodal data-such as pathology, imaging, and clinical information-and to perform integrative analyses. AI technologies can offer novel solutions for disease classification, tumor grading, histological subtyping, molecular subtyping, selection of chemotherapy regimens, risk stratification, treatment response prediction, report generation, and intelligent question-answering. This research provides important support for precision medicine and individualized treatment and has significant theoretical and practical implications. Conducting a prospective randomized controlled study better aligns with clinical application requirements and can accelerate the comprehensive deployment of AI systems.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pancancer

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital, Southern Medical University
    • Zhongshan, Guangdong, China, 513000
      • Zhongshan City People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. Age 18 years or older.
2. Patients with available digitized pathology slides, radiological imaging, and corresponding clinical data.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
ZSCPH validation dataset; Approximately 1,000 prospective patients across various disease types will have digitized scanned images, imaging information, and clinicopathological data provided, collected from Zhongshan People's Hospital (Zhongshan, Guangdong, China) between October 2025 and September 2030.
NFHSMU validation dataset; We conducted a prospective validation study to compare the diagnostic performance among pathologists, our multimodal artificial intelligence model . This study was initiated on October 1, 2025 at Nanfang Hospital, Southern Medical University (NFHSMU).
Randomized controlled trial; We conducted a prospective randomized controlled trial to compare the diagnostic performance among pathologists, the multimodal artificial intelligence model, and pathologist-with-model-assisted diagnosis at Nanfang Hospital of Southern Medical University (NFHSMU).The trial commenced data collection on October 1, 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under ROC curve (AUC)	Area under the curve	Diagnostic evaluation will be performed within 1 week when the WSIs or CT are obtained

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specificity	The true negative rate (TNR) of the diagnostic platform, which is the ratio between the number of negative individuals correctly categorized by platform and the total number of actual negative individuals (%).	Diagnostic evaluation will be performed within 1 week when the WSIs or CT are obtained
Sensitivity	The true positive rate (TPR) of the diagnostic platform, which is the ratio between the number of positive individuals correctly categorized by platform and the total number of actual positive individuals (%).	Diagnostic evaluation will be performed within 1 week when the WSIs or CT are obtained

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University
• Investigators: Study Director: Li Liang, Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Actual): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: NFEC-2025-602

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Requests for the data collected and analyzed in this study will be considered if the application is in line with public benefits and the applicant is willing to sign a data access agreement. Contact can be through the corresponding author.