Clinical Trial

Preliminary Evaluation of a Large Language Model-Based Tool for Complex Surgical Decision Support in Lung Cancer

Completed
View on ClinicalTrials.gov →
Summary
This study is an exploratory effect-size estimation study, with the following specific objectives: ① to estimate the point estimate and 95% confidence interval of the Win Ratio for the experimental group (GAPS-Agent) versus the control group (large language model) in blinded pairwise preference judgments by thoracic surgery expert adjudicators, to serve as a sample size planning parameter for subsequent multicenter confirmatory clinical trials; ② to preliminarily evaluate the value of GAPS-Agent within clinical workflows.The hypothesis of this study is as follows: compared with a general-purpose large language model without medical enhancement (control group), a structured agentic workflow optimized on the basis of the GAPS evaluation framework (GAPS-Agent, experimental group) can help junior resident physicians generate clinical decision plans for complex lung cancer cases that are more strongly preferred by senior thoracic surgery expert adjudicators.
Protocol Amendment History 2 changes
critical Trial status changed: Enrolling by Invitation → Completed 2026-07-28
notable Enrollment reduced: 12 -> 8 participants 2026-07-28
Trial Details
NCT Number NCT07654036
Lead Sponsor Peking University People's Hospital
Conditions Large Language Models, Lung Cancer (NSCLC)
Enrollment 8 participants
Start Date 2026-06-10
Primary Completion 2026-06-20 (estimated)
Study Completion 2026-06-21 (estimated)
Updated on ClinicalTrials.gov 2026-07-30