NCT07654036Befejeződött
Preliminary Evaluation of a Large Language Model-Based Tool for Complex Surgical Decision Support in Lung Cancer
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 30.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 8 (tényleges)
- Első benyújtás
- 2026. jún. 10.
- Kezdés
- 2026. jún. 10.
- Elsődleges befejezés
- 2026. jún. 20.
- Fő szponzor
- Peking University People's Hospital
- Betegségek
- Tüdőrák
- NCT-szám
- NCT07654036
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 8
- 2026. jún. 10. és az elsődleges befejezés (2026. jún. 20.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- 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.
Laborértékek
- 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.
Egyéb
- 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;
- Has a direct conflict of interest with any specific product among the two-arm tools of this study.
Kiket keres a vizsgálat
- 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;
- The current version of the NCCN guidelines does not provide an explicit recommendation covering the management of the case;
- Does not overlap with the GAPS evaluation set;
- 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;
- 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.
- Adjudication Expert Panel:
- Holds a valid and legally effective Physician Practice License of the People's Republic of China;
- Currently holds the rank of attending physician or above in a thoracic surgery department at a tertiary Class A hospital;
- Chairs or regularly participates in lung cancer multidisciplinary team (MDT) work in their department.
Életkor a regiszterben: 18 év – 65 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Peking University People's Hospital Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Beijing | Kína | Ismeretlen állapot |
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