Concordance Between Large Language Model and Multidisciplinary Team Recommendations in Rectal Cancer

Sponsor
Shandong Cancer Hospital and Institute
Study ID
NCT07595107
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Large Language Model Recommendation Generation — OTHER
    For each enrolled case, a standardized de-identified clinical summary will be entered into a locally deployed large language model using a fixed prompt and fixed inference parameters. The model will generate a structured treatment recommendation for concordance assessment. The large language model output will not be disclosed to the multidisciplinary team and will not influence actual patient management.

Study Details

This prospective single-center observational study will evaluate the concordance between recommendations generated by a locally deployed large language model and standardized multidisciplinary team recommendations for patients with rectal cancer. Consecutive adult patients with pathologically confirmed rectal adenocarcinoma who are scheduled for routine rectal cancer multidisciplinary team discussion will be enrolled. For each case, investigators will prepare a standardized de-identified clinical summary before the multidisciplinary team meeting. The same summary will be used for large language model generation and routine multidisciplinary team discussion. The large language model recommendation will not be disclosed to the clinical team and will not influence actual patient management. Concordance between the large language model recommendation and the multidisciplinary team reference recommendation will be assessed using predefined structured rules and blinded expert review.

Key Dates

First listed
May 19, 2026
Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Jun 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
180 participants (estimated)

Arms

  • Arm: Rectal Cancer MDT Cases
    Adult patients with pathologically confirmed rectal adenocarcinoma who are scheduled for routine rectal cancer multidisciplinary team discussion at the study center. For each enrolled case, a standardized de-identified clinical summary will be prepared and used for both large language model recommendation generation and routine multidisciplinary team discussion. The large language model output will not be disclosed to the clinical team and will not influence actual patient management.

Primary Outcome Measure

Percentage of Cases With Complete Concordance in Preferred Treatment Pathway Assessed Using a Structured Concordance Adjudication Form [ Time Frame: From enrollment to completion of recommendation adjudication for each case, up to 12 months. ]

Central Contacts

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