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Completed

NCT Number: NCT07592338

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Non-adenocarcinoma histology

Treatment and study plan

Treatment recommendation according to official German cancer guideline

Other

Detailed treatment recommendation according to the official guideline of the Association of the Scientific Medical Societies in Germany (AWMF; Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften),

Treatment recommendation of a LLM

Other

Structured clinical case summaries were analyzed by a GPT-4-class large language model to generate treatment recommendations.

Treatment recommendation of a multidisciplinary tumor board

Other

Detailed treatment recommendation according to the case-specific postoperative tumor board review.

Primary outcomes

  1. Concordance with guideline-based management

    Time frame: 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

Secondary outcomes

  1. Concordance with multidisciplinary tumor board decisions

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

    Agreement between LLM-generated recommendations and tumor board treatment strategies

  2. Reproducibility of LLM recommendations across repeated runs

    Time frame: 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.

  3. Characterization of discordant recommendations (e.g., overtreatment, undertreatment)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medizinische Hochschule Brandenburg Theodor Fontane

Other

Registry information

Official study title

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

Acronym: KITuKo

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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