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Prospective Assessment of Alignment Between Multimodal Artificial Intelligence and Multidisciplinary Team Decisions in Gastrointestinal Oncology

2026年7月31日 更新者:Sun Jin、Shanghai Minimally Invasive Surgery Center
This prospective, single-center observational study will evaluate the concordance between a multimodal artificial intelligence system and multidisciplinary team decisions in patients with gastrointestinal tumors. For each enrolled case, the AI system and the MDT will independently review the same available clinical information, including medical history, laboratory findings, imaging, pathology, and other relevant diagnostic data, and will generate recommendations regarding diagnosis, staging, treatment planning, and further examinations. An independent expert panel will assess the agreement, clinical appropriateness, and potential major errors of the two decision pathways. AI-generated recommendations will be used solely for research evaluation and will not directly influence patient care. The study aims to determine the feasibility, reliability, and safety of multimodal AI-assisted decision-making in real-world gastrointestinal oncology workflows.

研究概览

研究类型

观察性的

注册 (估计的)

69

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

    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200025
        • Ruijin hospital Shanghai Jiaotong University, School of Medicine
        • 接触:

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

Consecutive adult patients with suspected or confirmed gastric, colon, or rectal cancer who are scheduled for multidisciplinary team evaluation at Ruijin Hospital because of a clinical question related to diagnosis, staging, perioperative treatment, surgical planning, recurrence or metastasis, conversion therapy, response assessment, or another complex management decision. Eligible participants must have an identifiable clinical decision time point and sufficient clinical information to permit paired evaluation by the multimodal artificial intelligence system and the multidisciplinary team.

描述

Inclusion Criteria:

  1. Aged 18 years or older, with no restriction based on sex.
  2. Histologically confirmed gastric, colon, or rectal cancer; or highly suspected gastric, colon, or rectal malignancy based on clinical, endoscopic, or imaging findings, with further diagnostic, staging, or treatment planning required.
  3. Scheduled for multidisciplinary team evaluation at the study center because of an initial diagnosis, clinical staging, perioperative treatment, surgical planning, recurrence or metastasis, conversion therapy, treatment response assessment, or another complex clinical management question.
  4. A clearly identifiable clinical decision time point can be established, and the clinical information available before that time point can be defined.
  5. At the clinical decision time point, at least the basic medical history, the clinical question to be addressed, and at least one core source of information from endoscopy, pathology, or imaging are available. Completion of all examinations is not required, because missing examinations may be evaluated as part of diagnostic task planning.
  6. A corresponding multidisciplinary team recommendation regarding diagnostic tasks or the principal treatment decision can be obtained for comparison with the artificial intelligence output.
  7. Willing and able to understand the study and provide dated written informed consent.

Exclusion Criteria:

  1. Further examination confirms a condition other than gastric, colon, or rectal cancer, and the case is not applicable to the gastrointestinal oncology pathways evaluated in this study.
  2. The participant is undergoing routine follow-up or continuation of a previously established treatment plan and has no clinical question requiring additional diagnostic tasks, modification of the principal treatment pathway, or multidisciplinary team decision-making.
  3. A clear clinical decision time point cannot be established, or information available before and after the decision cannot be distinguished, preventing comparison of the artificial intelligence system and the multidisciplinary team under the same information conditions.
  4. Core clinical information is severely incomplete, such that the current stage of care and the clinical question cannot be identified and a clinically meaningful artificial intelligence output cannot be generated.
  5. A clear multidisciplinary team recommendation corresponding to the clinical decision time point cannot be obtained, or the multidisciplinary team documentation is insufficient for paired evaluation.
  6. The participant requires immediate resuscitation or urgent clinical management, and study recruitment could interfere with necessary medical care.
  7. The participant is unable to provide valid informed consent because of impaired consciousness, severe cognitive impairment, or another reason, and no ethics-approved proxy consent procedure is available for this study.
  8. The participant declines research use of the medical record, endoscopic, pathological, imaging, or other required clinical data.
  9. Any other condition that, in the investigator's judgment, could seriously affect participant rights, data compliance, or the reliability of the study results.

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
Patients With Gastrointestinal Tumors
Participants with gastric, colon, or rectal tumors who are prospectively enrolled and undergo parallel, independent clinical decision assessments by a multimodal artificial intelligence system and a multidisciplinary team using the same clinical information available at the predefined decision time point. AI-generated recommendations are used solely for research evaluation and do not directly influence clinical care.
Using the same clinical information available at the predefined decision time point, the institutional multidisciplinary team will independently formulate recommendations regarding diagnosis, staging, additional examinations, and treatment planning according to routine clinical practice. Clinical management will remain under the responsibility of the treating physicians and the multidisciplinary team. The MDT decision and the independently generated AI output will subsequently be compared and evaluated by an independent expert panel.
Available clinical information for each enrolled participant, including medical history, laboratory findings, endoscopic findings, imaging, pathology, and molecular testing results when available, will be entered into a multimodal artificial intelligence system. The system will independently generate a structured assessment of diagnosis, staging, additional diagnostic tasks, and treatment planning. The AI-generated output will be recorded solely for research comparison, will not be disclosed to the treating multidisciplinary team before its decision is finalized, and will not directly influence patient care.

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
Clinical Acceptability Concordance Rate Between the Multimodal Artificial Intelligence System and the Multidisciplinary Team
大体时间:At the predefined index clinical decision point, within 28 days after enrollment
The proportion of evaluable participants whose AI-generated diagnostic task plan and principal treatment recommendation are judged by an independent expert panel to be fully concordant with the MDT decision or a clinically acceptable alternative. Results will be reported as a percentage with a 95% confidence interval.
At the predefined index clinical decision point, within 28 days after enrollment

次要结果测量

结果测量
措施说明
大体时间
Full Concordance Rate
大体时间:At the predefined index clinical decision point, within 28 days after enrollment
The proportion of evaluable participants whose AI-generated diagnostic task plan and principal treatment recommendation are judged to be fully concordant with the MDT decision.
At the predefined index clinical decision point, within 28 days after enrollment
Major Discordance Rate
大体时间:At the predefined index clinical decision point, within 28 days after enrollment
The proportion of evaluable participants whose AI-generated recommendation is judged to contain a major discordance with potential for clinically significant harm.
At the predefined index clinical decision point, within 28 days after enrollment
Successful AI Output Rate
大体时间:At the predefined index clinical decision point, within 28 days after enrollment
The proportion of enrolled participants for whom the AI system successfully generates an evaluable diagnostic task plan and principal treatment recommendation.
At the predefined index clinical decision point, within 28 days after enrollment

其他结果措施

结果测量
措施说明
大体时间
Distribution of AI-MDT Discordance Types
大体时间:At completion of independent expert evaluation, within 28 days after enrollment
The number and percentage of discordant cases classified by type, including diagnostic or staging errors, inappropriate additional testing, treatment selection errors, treatment sequencing errors, and potential safety risks.
At completion of independent expert evaluation, within 28 days after enrollment

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。

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8月5日

初级完成 (估计的)

2027年8月5日

研究完成 (估计的)

2028年8月5日

研究注册日期

首次提交

2026年7月31日

首先提交符合 QC 标准的

2026年7月31日

首次发布 (实际的)

2026年8月5日

研究记录更新

最后更新发布 (实际的)

2026年8月5日

上次提交的符合 QC 标准的更新

2026年7月31日

最后验证

2026年7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

IPD 计划说明

There is currently no plan to share individual participant data because the study involves sensitive clinical records, medical images, and digital pathology data with potential re-identification risks. Aggregate study results will be reported.

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

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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