Preliminary Evaluation of a Large Language Model-Based Tool for Complex Surgical Decision Support… (NCT07654036) | Clinical Trial Compass
By InvitationNot Applicable
Preliminary Evaluation of a Large Language Model-Based Tool for Complex Surgical Decision Support in Lung Cancer
China12 participantsStarted 2026-06-10
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Resident Physician Subjects:
. Holds a valid and legally effective Physician Practice License of the People's Republic of China;
. Currently holds the rank of resident physician in a thoracic surgery department at a tertiary Class A (3A) hospital;
. Agrees to complete all assessment tasks of the main study phase in accordance with the study protocol;
. Can guarantee the time and effort required to complete all assessment tasks of the main study.
. Study Cases:
. The case was discussed at the Thoracic Oncology Multidisciplinary Team (MDT) conference of Peking University People's Hospital between January 2025 and May 2026;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial seems to be testing an AI tool to help surgeons make decisions about lung cancer treatment — can you explain what role this large language model would actually play in my care, and would it be making recommendations about my surgery?
2Since this study is 'enrolling by invitation only,' can you tell me whether I might be eligible to participate, and what criteria are being used to select patients?
3The main thing this trial is measuring is called an 'Overall plan Win Ratio' — can you explain in plain terms what that means and how it would reflect whether the AI's surgical planning suggestions are actually better than the current approach?
4Since this is listed as Phase NA, which I understand means it's more of an evaluation study than a traditional drug or device trial, does participating change anything about the actual surgical treatment I would receive, or is the AI tool being tested separately from my care decisions?
5If this AI decision-support tool is still being evaluated, what would happen if its recommendations conflicted with your own clinical judgment — who ultimately decides my treatment plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall plan Win Ratio
Timeframe: Measured at the time when experts completed their preference judgements. Calculated up to 3 weeks after the preference judgements.
. The current version of the NCCN guidelines does not provide an explicit recommendation covering the management of the case;
Exclusion criteria
. Resident Physician Subjects:
. Has previously participated in the construction of the GAPS evaluation set or the development of GAPS-Agent;
. Unable to complete the tasks of the study phase.
. Study Cases:
. 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;
. Decision-making for the case is strictly dependent on non-text information.
. Adjudication Expert Panel:
. Participated in the construction of the GAPS evaluation set, the content validity verification, or the development of GAPS-Agent for this study;