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临床试验/NCT06002425
NCT06002425招募中不适用

Application of Large Language Models in the Recommendation of Treatment Plans for Gastrointestinal Cancers

Chinese Academy of Sciences10 个研究点 分布在 4 个国家目标入组 400 人开始时间: 2023年8月29日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
10
主要终点
Influence Rate of ChatGPT on Treatment Plans

研究概览

简要总结

This study will evaluate the utility of ChatGPT in recommending treatment plans for patients with gastrointestinal cancers, using both retrospective and prospective data.

详细描述

The medical records of over 1,200 patients with gastrointestinal cancers will be collected retrospectively from participating hospitals. This data will be split into an exploratory dataset (n=200) and a validation dataset (n>=1,000). Within the exploratory dataset, various prompt methods will be used to determine the treatment plans suggested by ChatGPT. Additionally, several clinicians of varied seniority levels will provide their treatment recommendations. For the validation dataset, ChatGPT's suggestions for treatment plans will undergo both qualitative and quantitative assessments by a multidisciplinary consultation (MDT) team. The recommendations from ChatGPT will then be compared with those from the clinicians.

Furthermore, this study will incorporate a prospective dataset comprising 400 participants with gastrointestinal cancers. The participants will be randomly allocated to either a control group (n=200) or a ChatGPT-Assisted group (n=200). In the control group, treatment plan recommendations will solely be provided by the clinicians and will guide subsequent treatments. In the ChatGPT-Assisted group, initial treatment plan recommendations will be independently proposed by both ChatGPT and the clinicians. Based on ChatGPT's suggestions, clinicians might selectively adjust their initial plans. Participants will then receive treatments as per these refined plans. Within the ChatGPT-Assisted group, the treatment plans of the initial 100 participants will be evaluated to determine the percentage of patients whose treatment plans are influenced by ChatGPT. Subsequently, the proportion of participants in the entire ChatGPT-Assisted group with treatment plans modified by ChatGPT will be calculated. The study will further monitor the 3-year progression-free survival (PFS) and the 5-year overall survival (OS) rates, contrasting the outcomes between the control and ChatGPT-assisted groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years, both male and female.
  • Pathologically confirmed diagnosis of gastrointestinal cancer (gastric cancer or colorectal Cancer).
  • Detailed medical records available prior to treatment (including chief complaint, history of present illness, radiological examinations, pathological examinations, laboratory tests, etc.).
  • Participants will receive complete treatment in the participating hospitals.

排除标准

  • Participants with cancers other than gastrointestinal cancers.
  • Participants who receive treatment in multiple hospitals.

结局指标

主要结局

Influence Rate of ChatGPT on Treatment Plans

时间窗: Within 24 hours after the treatment plan is determined from the onset of study participation.

The percentage of the initial 100 participants and the overall participants in the ChatGPT-Assisted group whose treatment plans are adjusted by clinicians after consulting with ChatGPT.

次要结局

  • 3-year Progression-Free Survival (PFS) Rate(3 years)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Di Dong

Professor

Chinese Academy of Sciences

研究点 (10)

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