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

NCT07592338 | Completed

• 1 other identifier: KITuKo
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Cancer (GC); Colorectal Cancer; Pancreatic Cancer

Keywords

Colorectal Neoplasms; Stomach Neoplasms; Pancreatic Neoplasms; Artificial Intelligence; Clinical Decision Support Systems

Outcome Measures

Primary Outcomes (1)

• Concordance with guideline-based management

  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

Secondary Outcomes (3)

• Concordance with multidisciplinary tumor board decisions

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

• Reproducibility of LLM recommendations across repeated runs

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

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

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

Study Arms (3)

Pancreatic cancer

Patients with pancreatic cancer

Other: Treatment recommendation according to official German cancer guideline; Other: Treatment recommendation of a LLM; Other: Treatment recommendation of a multidisciplinary tumor board

Gastric cancer

Patients with gastric cancer

Other: Treatment recommendation according to official German cancer guideline; Other: Treatment recommendation of a LLM; Other: Treatment recommendation of a multidisciplinary tumor board

Colorectal cancer

Patients with colorectal cancer

Other: Treatment recommendation according to official German cancer guideline; Other: Treatment recommendation of a LLM; Other: Treatment recommendation of a multidisciplinary tumor board

Interventions

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),

Colorectal cancer; Gastric cancer; Pancreatic cancer

Treatment recommendation of a LLM OTHER

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

Colorectal cancer; Gastric cancer; Pancreatic cancer

Treatment recommendation of a multidisciplinary tumor board OTHER

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

Colorectal cancer; Gastric cancer; Pancreatic cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• Non-adenocarcinoma histology

Sponsors & Collaborators

• Medizinische Hochschule Brandenburg Theodor Fontane: lead

Study Sites (1)

University Hospital Brandenburg

Brandenburg an der Havel, Brandenburg, 14770, Germany

Location

MeSH Terms

Conditions

Stomach Neoplasms; Colorectal Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 18, 2026
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 25, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)