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AI-Based DeepGEM Tool for Predicting Gene Mutations in NSCLC Patients: A Randomized Controlled Study

NCT07110259 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 950

Last updated 2025-08-07

No results posted yet for this study

Summary

This prospective, multicenter, randomized controlled trial aims to evaluate the clinical utility of DeepGEM, an artificial intelligence (AI)-based mutation prediction tool based on histopathological whole-slide images, in patients with non-small cell lung cancer (NSCLC). The study will assess whether DeepGEM can facilitate molecular testing, increase targeted therapy utilization, and improve survival outcomes in a real-world clinical setting. Patients with stage II-IV treatment-naïve NSCLC and qualified pathology slides for DeepGEM analysis will be enrolled. Eligible participants with AI-predicted EGFR, ALK, or ROS1 mutations will be randomized in a 4:1 ratio to either the DeepGEM-informed group (clinicians can access AI results to guide further testing and treatment) or the standard care group (clinicians are blinded to AI results and follow routine care).

Conditions

  • Non Small Cell Lung Caner

Interventions

OTHER

DeepGEM-guided Molecular Testing and Treatment

Artificial intelligence-based mutation prediction using DeepGEM to guide clinical decision-making for molecular testing and therapy selection.

OTHER

Standard Diagnostic Pathway

DeepGEM is used for eligibility screening, but its results are withheld. Clinicians manage patients per standard diagnostic and treatment practices.

Sponsors & Collaborators

  • Guangzhou Kingmed Diagnostics Co., Ltd.

    collaborator UNKNOWN

  • Jianxing He

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2028-07-31
Completion
2028-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07110259 on ClinicalTrials.gov