Prospective Real-World Study of Multimodal AI

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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07269236

Enrollment

2000

Registered

2025-12-08

Start date

2025-10-01

Completion date

2030-09-30

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancancer

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Specificity	Diagnostic evaluation will be performed within 1 week when the WSIs or CT are obtained	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 (%).
Sensitivity	Diagnostic evaluation will be performed within 1 week when the WSIs or CT are obtained	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 (%).

Countries

China

Outcome results