Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

14. Mai 2026 aktualisiert von: 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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

30

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-adenocarcinoma histology

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Darmkrebs
Patienten mit Darmkrebs
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Concordance with guideline-based management
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Concordance with multidisciplinary tumor board decisions
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Januar 2025

Primärer Abschluss (Tatsächlich)

1. Januar 2026

Studienabschluss (Tatsächlich)

25. Februar 2026

Studienanmeldedaten

Zuerst eingereicht

4. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. Mai 2026

Zuerst gepostet (Tatsächlich)

18. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

18. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren