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

14. mai 2026 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

30

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-adenocarcinoma histology

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Tykktarmskreft
Pasienter med tykktarmskreft
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Concordance with guideline-based management
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Concordance with multidisciplinary tumor board decisions
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2025

Primær fullføring (Faktiske)

1. januar 2026

Studiet fullført (Faktiske)

25. februar 2026

Datoer for studieregistrering

Først innsendt

4. mai 2026

Først innsendt som oppfylte QC-kriteriene

14. mai 2026

Først lagt ut (Faktiske)

18. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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