- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07592338
Agreement Between Large Language Model-Generated Treatment Recommendations With Guideline-Based and Tumor Board Decisions in Gastrointestinal Cancer (KITuKo)
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Brandenburg
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Brandenburg an der Havel, Brandenburg, Alemania, 14770
- University Hospital Brandenburg
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Histologically confirmed pancreatic, gastric, or colorectal adenocarcinoma
- Treatment discussed in a multidisciplinary tumor board
Exclusion Criteria:
- Non-adenocarcinoma histology
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Cáncer colonrectal
Pacientes con cáncer colorrectal
|
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
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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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Concordance with guideline-based management
Periodo de tiempo: At the time of multidisciplinary tumor board evaluation up to 4 weeks after surgery
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Agreement between LLM-generated recommendations and AWMF guideline-supported treatment strategies
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At the time of multidisciplinary tumor board evaluation up to 4 weeks after surgery
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Concordance with multidisciplinary tumor board decisions
Periodo de tiempo: 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
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|
Reproducibility of LLM recommendations across repeated runs
Periodo de tiempo: 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.
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At the time of multidisciplinary tumor board evaluation up to 4 weeks after surgery
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Characterization of discordant recommendations (e.g., overtreatment, undertreatment)
Periodo de tiempo: At the time of multidisciplinary tumor board evaluation up to 4 weeks after surgery
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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
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Neoplasias por sitio
- Neoplasias
- Enfermedades intestinales
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Enfermedades del Estómago
- Neoplasias Intestinales
- Enfermedades Rectales
- Neoplasias de glándulas endocrinas
- Enfermedades pancreáticas
- Enfermedades del Colon
- Neoplasias de Estómago
- Neoplasias colorrectales
- Neoplasias pancreáticas
Otros números de identificación del estudio
- KITuKo
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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