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Concordance Between Large Language Model and Multidisciplinary Team Recommendations in Rectal Cancer

2026年5月16日 更新者:Jinbo Yue、Shandong Cancer Hospital and Institute

A Prospective Single-Center Observational Study Evaluating Concordance Between Large Language Model-Generated Recommendations and Multidisciplinary Team Recommendations in Rectal Cancer

This prospective single-center observational study will evaluate the concordance between recommendations generated by a locally deployed large language model and standardized multidisciplinary team recommendations for patients with rectal cancer.

Consecutive adult patients with pathologically confirmed rectal adenocarcinoma who are scheduled for routine rectal cancer multidisciplinary team discussion will be enrolled. For each case, investigators will prepare a standardized de-identified clinical summary before the multidisciplinary team meeting. The same summary will be used for large language model generation and routine multidisciplinary team discussion.

The large language model recommendation will not be disclosed to the clinical team and will not influence actual patient management. Concordance between the large language model recommendation and the multidisciplinary team reference recommendation will be assessed using predefined structured rules and blinded expert review.

研究概览

详细说明

Management of rectal cancer often requires multidisciplinary decision-making based on tumor location, pelvic magnetic resonance imaging findings, clinical stage, mesorectal fascia or circumferential resection margin status, extramural vascular invasion, lateral lymph node status, metastatic status, previous treatment, surgical feasibility, organ preservation considerations, and patient preferences. Large language models have shown potential in medical information processing and clinical decision support, but their performance in complex oncologic decision-making has not been fully validated.

This study is designed as a prospective, single-center, observational concordance study. Consecutive patients with rectal adenocarcinoma who are scheduled for routine rectal cancer multidisciplinary team discussion at the study center will be screened. Before the multidisciplinary team meeting, investigators will prepare a standardized de-identified case summary using a predefined template. The summary will include relevant demographic information, clinical status, endoscopic findings, pathological and molecular information, key imaging findings, previous treatments, and patient preferences or practical constraints when available.

The same standardized case summary will be used as the input for a locally deployed large language model. A fixed prompt, fixed model version, and fixed inference parameters will be used throughout the study. Each case will be processed in an independent session, without additional interactive prompting or manual correction. The model will not use internet access, external knowledge retrieval, or retrieval-augmented generation during the study.

Routine multidisciplinary team discussion will proceed independently according to standard clinical workflow. The large language model output will not be provided to the multidisciplinary team and will not be used to guide patient treatment. Actual treatment decisions will be made by the treating physicians and multidisciplinary team according to routine clinical practice.

After both recommendations have been generated, the large language model recommendation and the multidisciplinary team recommendation will be transformed into a structured format. The structured recommendations will include the preferred treatment pathway, specific treatment plan, acceptable alternative options, key rationale, and need for additional examinations or information. De-identified and randomly ordered recommendations will then be evaluated using predefined concordance rules and blinded expert review.

The primary objective is to estimate the complete concordance rate between the large language model recommendation and the multidisciplinary team reference recommendation for the preferred treatment pathway. Secondary objectives include evaluation of concordance in specific treatment implementation, acceptable alternative options, identification of additional examinations or information needs, and the rate of major discordance. Exploratory analyses will assess patterns of major discordance and clinical features associated with concordant or discordant recommendations.

研究类型

观察性的

注册 (估计的)

180

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Shandong
      • Jinan、Shandong、中国、0531
        • Department of Radiation Oncology, Shandong Cancer Hospital and Institute

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

The study population will consist of consecutive adult patients with pathologically confirmed rectal adenocarcinoma who are scheduled for routine rectal cancer multidisciplinary team discussion at Shandong Cancer Hospital and Institute. Eligible cases must have sufficient clinical, pathological, and imaging information to allow preparation of a standardized de-identified case summary for concordance assessment between large language model-generated recommendations and multidisciplinary team reference recommendations.

描述

Inclusion Criteria:

  1. Age 18 years or older.
  2. Pathologically confirmed rectal adenocarcinoma.
  3. Scheduled for routine rectal cancer multidisciplinary team discussion at the study center.
  4. Availability of complete or substantially complete standardized decision-making information before multidisciplinary team discussion, including clinical, pathological, and key imaging information.
  5. Availability of a structured pelvic magnetic resonance imaging report meeting the requirements of the institutional rectal cancer multidisciplinary team, including at least tumor location, clinical T stage, clinical N stage, circumferential resection margin or mesorectal fascia status, extramural vascular invasion status, and lateral lymph node status.
  6. Presence of a defined clinical treatment decision question.
  7. Clinical data can be sufficiently de-identified for research use.

Exclusion Criteria:

  1. Severely incomplete clinical information preventing preparation of a standardized case summary.
  2. Non-rectal primary tumor.
  3. Routine follow-up cases without a defined treatment decision question.
  4. Absence of a structured pelvic magnetic resonance imaging report meeting the requirements of the institutional rectal cancer multidisciplinary team, or missing pelvic magnetic resonance imaging elements that preclude key rectal cancer decision-making.
  5. Cases containing sensitive information considered unsuitable for large language model input by the study team.
  6. Cases in which a definitive treatment decision has already been made before the multidisciplinary team discussion and the meeting serves only as a formal review.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Rectal Cancer MDT Cases
Adult patients with pathologically confirmed rectal adenocarcinoma who are scheduled for routine rectal cancer multidisciplinary team discussion at the study center. For each enrolled case, a standardized de-identified clinical summary will be prepared and used for both large language model recommendation generation and routine multidisciplinary team discussion. The large language model output will not be disclosed to the clinical team and will not influence actual patient management.
For each enrolled case, a standardized de-identified clinical summary will be entered into a locally deployed large language model using a fixed prompt and fixed inference parameters. The model will generate a structured treatment recommendation for concordance assessment. The large language model output will not be disclosed to the multidisciplinary team and will not influence actual patient management.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Percentage of Cases With Complete Concordance in Preferred Treatment Pathway Assessed Using a Structured Concordance Adjudication Form
大体时间:From enrollment to completion of recommendation adjudication for each case, up to 12 months.
Percentage of enrolled cases in which the preferred treatment pathway recommended by the large language model is completely concordant with the multidisciplinary team reference recommendation, as assessed using a predefined structured concordance adjudication form. The unit of measure is percentage of cases.
From enrollment to completion of recommendation adjudication for each case, up to 12 months.

次要结果测量

结果测量
措施说明
大体时间
Percentage of Cases With Concordant Specific Treatment Implementation Assessed Using a Structured Concordance Adjudication Form
大体时间:From enrollment to completion of recommendation adjudication for each case, up to 12 months.
Percentage of cases in which the large language model recommendation and the multidisciplinary team reference recommendation are rated as concordant for the specific treatment implementation plan using a predefined structured concordance adjudication form and blinded expert review. The unit of measure is percentage of cases.
From enrollment to completion of recommendation adjudication for each case, up to 12 months.
Percentage of Applicable Cases With Concordant Alternative Treatment Options Assessed Using a Structured Concordance Adjudication Form
大体时间:From enrollment to completion of recommendation adjudication for each case, up to 12 months.
Percentage of applicable cases in which the large language model recommendation and the multidisciplinary team reference recommendation are rated as concordant regarding acceptable alternative treatment options using a predefined structured concordance adjudication form and blinded expert review. The unit of measure is percentage of applicable cases.
From enrollment to completion of recommendation adjudication for each case, up to 12 months.
Percentage of Cases With Concordant Identification of Additional Examination or Information Needs Assessed Using a Structured Concordance Adjudication Form
大体时间:From enrollment to completion of recommendation adjudication for each case, up to 12 months.
Percentage of cases in which the large language model recommendation and the multidisciplinary team reference recommendation agree on whether additional examinations, restaging, or key information are needed before treatment decision-making, as assessed using a predefined structured concordance adjudication form. The unit of measure is percentage of cases.
From enrollment to completion of recommendation adjudication for each case, up to 12 months.
Percentage of Cases With Major Discordance Assessed by Blinded Expert Review
大体时间:From enrollment to completion of recommendation adjudication for each case, up to 12 months.
Percentage of enrolled cases in which differences between the large language model recommendation and the multidisciplinary team reference recommendation are classified as major discordance using a predefined structured adjudication form and blinded expert review. Major discordance is defined as a clinically substantial difference potentially associated with undertreatment, overtreatment, incorrect treatment sequencing, inappropriate organ preservation or local control judgment, or omission of necessary additional evaluation. The unit of measure is percentage of cases.
From enrollment to completion of recommendation adjudication for each case, up to 12 months.
Cohen's Kappa Coefficient for Inter-Rater Agreement in Blinded Expert Assessment
大体时间:At completion of blinded expert review, up to 12 months.
Inter-rater agreement between independent blinded reviewers for judgment-based endpoints will be assessed using Cohen's kappa coefficient. Judgment-based endpoints include specific treatment implementation concordance, alternative treatment option concordance, major discordance classification, and failure mode classification when applicable. The unit of measure is the kappa coefficient.
At completion of blinded expert review, up to 12 months.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Jinbo Yue, MD, PhD、Shandong Cancer Hospital And Institute

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2027年6月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2026年5月11日

首先提交符合 QC 标准的

2026年5月16日

首次发布 (实际的)

2026年5月19日

研究记录更新

最后更新发布 (实际的)

2026年5月19日

上次提交的符合 QC 标准的更新

2026年5月16日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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