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Agreement Between Large Language Model-Generated Treatment Recommendations With Guideline-Based and Tumor Board Decisions in Gastrointestinal Cancer (KITuKo)

2026년 5월 14일 업데이트: Rene Mantke, Medizinische Hochschule Brandenburg Theodor Fontane

Concordance of Large Language Model-Generated Treatment Recommendations With Multidisciplinary Tumor Board and Guideline-Based Decisions in Gastrointestinal Cancer: A Retrospective Cohort Study

The goal of this observational study is to learn whether a computer program can suggest cancer treatments that match expert recommendations for people with gastrointestinal cancer (cancer of the pancreas, stomach, or colon and rectum).

The main questions it aims to answer are:

  • Do the treatment suggestions from the computer program match current medical guidelines?
  • Do these suggestions match decisions made by a multidisciplinary tumor board (a team of cancer specialists)?

Researchers will review existing medical records from people who have already been treated for these cancers. They will enter key clinical information into a computer program that uses artificial intelligence (AI). The program will generate treatment suggestions for each case.

Researchers will then compare these suggestions with:

  • guideline-based treatment recommendations
  • decisions made by the tumor board

This study will help researchers understand whether AI tools could support doctors in making cancer treatment decisions in the future.

연구 개요

상세 설명

Gastrointestinal cancers require complex treatment planning that often involves surgery, systemic therapy, and multidisciplinary coordination. Clinical decision-making is typically guided by evidence-based recommendations and discussed in multidisciplinary tumor boards. However, the increasing complexity of treatment strategies and guideline frameworks can make consistent and reproducible decision-making challenging in routine clinical practice.

Recent advances in artificial intelligence have enabled the development of large language models (LLMs) that can process structured clinical information and generate text-based recommendations. These systems may offer a scalable approach to support clinical workflows, but their ability to produce reliable and clinically appropriate treatment suggestions in oncology remains uncertain.

This study evaluates the performance of an LLM-based system in the context of gastrointestinal oncology using retrospectively collected clinical case data. Structured case summaries derived from routine clinical documentation are used as standardized input. The model generates treatment recommendations under controlled conditions, allowing systematic comparison with established clinical reference standards.

The analysis focuses on the level of agreement between model-generated recommendations and established decision-making frameworks. In addition, the study explores how model performance varies across different clinical scenarios, including varying levels of disease complexity. Particular attention is given to situations in which recommendations differ, in order to better understand potential limitations of the model and identify patterns that may be clinically relevant.

Furthermore, the study examines the consistency of model outputs when the same clinical information is processed multiple times. This provides insight into the stability and reproducibility of the system, which are important considerations for potential real-world use.

The findings of this study are intended to inform the potential role of LLM-based tools as supportive systems in clinical decision-making. The study does not evaluate clinical outcomes or patient benefit, but instead focuses on agreement with established standards and expert-driven decisions as an initial step in assessing feasibility and safety.

연구 유형

관찰

등록 (실제)

30

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Brandenburg
      • Brandenburg an der Havel, Brandenburg, 독일, 14770
        • University Hospital Brandenburg

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

The study population consists of adult patients with gastrointestinal adenocarcinoma treated at a tertiary care academic center in the Federal State of Brandenburg, Germany. The population is derived from routine clinical practice and includes patients whose cases were evaluated in a multidisciplinary tumor board.

설명

Inclusion Criteria:

  • Histologically confirmed pancreatic, gastric, or colorectal adenocarcinoma
  • Treatment discussed in a multidisciplinary tumor board

Exclusion Criteria:

  • Non-adenocarcinoma histology

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
대장암
대장암 환자
Detailed treatment recommendation according to the official guideline of the Association of the Scientific Medical Societies in Germany (AWMF; Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften),
Structured clinical case summaries were analyzed by a GPT-4-class large language model to generate treatment recommendations.
Detailed treatment recommendation according to the case-specific postoperative tumor board review.
Pancreatic cancer
Patients with pancreatic cancer
Detailed treatment recommendation according to the official guideline of the Association of the Scientific Medical Societies in Germany (AWMF; Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften),
Structured clinical case summaries were analyzed by a GPT-4-class large language model to generate treatment recommendations.
Detailed treatment recommendation according to the case-specific postoperative tumor board review.
Gastric cancer
Patients with gastric cancer
Detailed treatment recommendation according to the official guideline of the Association of the Scientific Medical Societies in Germany (AWMF; Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften),
Structured clinical case summaries were analyzed by a GPT-4-class large language model to generate treatment recommendations.
Detailed treatment recommendation according to the case-specific postoperative tumor board review.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Concordance with guideline-based management
기간: At the time of multidisciplinary tumor board evaluation up to 4 weeks after surgery
Agreement between LLM-generated recommendations and AWMF guideline-supported treatment strategies
At the time of multidisciplinary tumor board evaluation up to 4 weeks after surgery

2차 결과 측정

결과 측정
측정값 설명
기간
Concordance with multidisciplinary tumor board decisions
기간: At the time of multidisciplinary tumor board evaluation up to 4 weeks after surgery
Agreement between LLM-generated recommendations and tumor board treatment strategies
At the time of multidisciplinary tumor board evaluation up to 4 weeks after surgery
Reproducibility of LLM recommendations across repeated runs
기간: At the time of multidisciplinary tumor board evaluation up to 4 weeks after surgery
Structured clinical case vignettes were entered into ChatGPT using a standardized prompt template. To assess within-model reproducibility, each clinical vignette was analyzed in 3 independent model sessions performed on different days using identical clinical input.
At the time of multidisciplinary tumor board evaluation up to 4 weeks after surgery
Characterization of discordant recommendations (e.g., overtreatment, undertreatment)
기간: At the time of multidisciplinary tumor board evaluation up to 4 weeks after surgery

Overtreatment was defined as an LLM-generated recommendation exceeding the intensity of the reference recommendation.

Undertreatment was defined as omission of a recommended treatment or recommendation of a less intensive strategy.

At the time of multidisciplinary tumor board evaluation up to 4 weeks after surgery

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 1월 1일

기본 완료 (실제)

2026년 1월 1일

연구 완료 (실제)

2026년 2월 25일

연구 등록 날짜

최초 제출

2026년 5월 4일

QC 기준을 충족하는 최초 제출

2026년 5월 14일

처음 게시됨 (실제)

2026년 5월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 14일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Individual participant data will not be shared. The dataset consists of retrospective, pseudonymized clinical data from a single institution, and sharing is restricted due to data protection regulations and institutional policies.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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