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

NCT07595107 | Not Yet Recruiting

• 1 other identifier: LLM-MDT-RECTAL-001
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rectal Cancer

Keywords

Large Language Model; Multidisciplinary Team; Rectal Cancer; Clinical Decision Support; Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

• Percentage of Cases With Complete Concordance in Preferred Treatment Pathway Assessed Using a Structured Concordance Adjudication Form

  Percentage of enrolled cases in which the preferred treatment pathway recommended by the large language model is completely concordant with the multidisciplinary team reference recommendation, as assessed using a predefined structured concordance adjudication form. The unit of measure is percentage of cases.

  From enrollment to completion of recommendation adjudication for each case, up to 12 months.

Secondary Outcomes (5)

• Percentage of Cases With Concordant Specific Treatment Implementation Assessed Using a Structured Concordance Adjudication Form

  From enrollment to completion of recommendation adjudication for each case, up to 12 months.

• Percentage of Applicable Cases With Concordant Alternative Treatment Options Assessed Using a Structured Concordance Adjudication Form

  From enrollment to completion of recommendation adjudication for each case, up to 12 months.

• Percentage of Cases With Concordant Identification of Additional Examination or Information Needs Assessed Using a Structured Concordance Adjudication Form

  From enrollment to completion of recommendation adjudication for each case, up to 12 months.

• Percentage of Cases With Major Discordance Assessed by Blinded Expert Review

  From enrollment to completion of recommendation adjudication for each case, up to 12 months.

• Cohen's Kappa Coefficient for Inter-Rater Agreement in Blinded Expert Assessment

  At completion of blinded expert review, up to 12 months.

Study Arms (1)

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.

Other: Large Language Model Recommendation Generation

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.

Rectal Cancer MDT Cases

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 will consist of consecutive adult patients with pathologically confirmed rectal adenocarcinoma who are scheduled for routine rectal cancer multidisciplinary team discussion at Shandong Cancer Hospital and Institute. Eligible cases must have sufficient clinical, pathological, and imaging information to allow preparation of a standardized de-identified case summary for concordance assessment between large language model-generated recommendations and multidisciplinary team reference recommendations.

You may qualify if:

• Age 18 years or older.
• Pathologically confirmed rectal adenocarcinoma.
• Scheduled for routine rectal cancer multidisciplinary team discussion at the study center.
• Availability of complete or substantially complete standardized decision-making information before multidisciplinary team discussion, including clinical, pathological, and key imaging information.
• Availability of a structured pelvic magnetic resonance imaging report meeting the requirements of the institutional rectal cancer multidisciplinary team, including at least tumor location, clinical T stage, clinical N stage, circumferential resection margin or mesorectal fascia status, extramural vascular invasion status, and lateral lymph node status.
• Presence of a defined clinical treatment decision question.
• Clinical data can be sufficiently de-identified for research use.

You may not qualify if:

• Severely incomplete clinical information preventing preparation of a standardized case summary.
• Non-rectal primary tumor.
• Routine follow-up cases without a defined treatment decision question.
• Absence of a structured pelvic magnetic resonance imaging report meeting the requirements of the institutional rectal cancer multidisciplinary team, or missing pelvic magnetic resonance imaging elements that preclude key rectal cancer decision-making.
• Cases containing sensitive information considered unsuitable for large language model input by the study team.
• Cases in which a definitive treatment decision has already been made before the multidisciplinary team discussion and the meeting serves only as a formal review.

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (1)

Department of Radiation Oncology, Shandong Cancer Hospital and Institute

Jinan, Shandong, 0531, China

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Jinbo Yue, MD, PhD

  Shandong Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinbo Yue, MD, PhD

CONTACT

053167626929; jbyue@sdfmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)