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Completed
NCT07654036
Preliminary Evaluation of a Large Language Model-Based Tool for Complex Surgical Decision Support in Lung Cancer
Conditions: Large Language Models, Lung Cancer (NSCLC)
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 8
Sponsor: Peking University People's Hospital
Location: Peking University People's Hospital Beijing Beijing Municipality
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.
Eligibility Criteria
Inclusion Criteria:
1. Resident Physician Subjects:
1. Holds a valid and legally effective Physician Practice License of the People's Republic of China;
2. Currently holds the rank of resident physician in a thoracic surgery department at a tertiary Class A (3A) hospital;
3. Agrees to complete all assessment tasks of the main study phase in accordance with the study protocol;
4. Can guarantee the time and effort required to complete all assessment tasks of the main study.
2. Study Cases:
1. The case was discussed at the Thoracic Oncology Multidisciplinary Team (MDT) conference of Peking University People's Hospital between January 2025 and May 2026;
2. The current version of the NCCN guidelines does not provide an explicit recommendation covering the management of the case;
3. Does not overlap with the GAPS evaluation set;
4. The case is presented in pure text in a structured format, with all direct and indirect identifiers removed and complete de-identification performed prior to inclusion;
5. From the pool of eligible cases, 12 cases will be randomly drawn using Python (numpy.random, with a fixed and archived seed) to serve as the main study cases. The cases will cover 6 themes (chest mass of undetermined diagnosis, early-stage lung cancer, locally advanced lung cancer, oligometastatic/oligoprogressive disease, special intraoperative situations, and tumor recurrence), with 1 - 4 cases per theme.
3. Adjudication Expert Panel:
1. Holds a valid and legally effective Physician Practice License of the People's Republic of China;
2. Currently holds the rank of attending physician or above in a thoracic surgery department at a tertiary Class A hospital;
3. Chairs or regularly participates in lung cancer multidisciplinary team (MDT) work in their department.
Exclusion Criteria:
1. Resident Physician Subjects:
1. Has previously participated in the construction of the GAPS evaluation set or the development of GAPS-Agent;
2. Unable to complete the tasks of the study phase.
2. Study Cases:
1. Key case information is missing, such as text-form data on pathology (including IHC/NGS), imaging, laboratory tests, prior medical history, comorbidities, or PS score;
2. Decision-making for the case is strictly dependent on non-text information.
3. Adjudication Expert Panel:
1. Participated in the construction of the GAPS evaluation set, the content validity verification, or the development of GAPS-Agent for this study;
2. Has a direct conflict of interest with any specific product among the two-arm tools of this study.
Source: ClinicalTrials.gov (NCT07654036). StuddyBuddy aggregates publicly available trial information.