Not_yet_recruitingNCT07595107

A Prospective Single-Center Observational Study Evaluating Concordance Between Large Language Model-Generated Recommendations and Multidisciplinary Team Recommendations in Rectal Cancer

Sponsor: Shandong Cancer Hospital and Institute

Trial Details

ConditionRectal Cancer
InterventionLarge Language Model Recommendation Generation
StatusNot_yet_recruiting
Participants180
Est. Completion1 June 2027
Last Updated19 May 2026

Primary Outcome

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

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: 1. Age 18 years or older. 2. Pathologically confirmed rectal adenocarcinoma. 3. Scheduled for routine rectal cancer multidisciplinary team discussion at the study center. 4. Availability of complete or substantially complete standardized decision-making information before multidisciplinary team discussion, including clinical, pathological, and key imaging information. 5. 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. 6. Presence of a defined clinical treatment decision question. 7. Clinical data can be sufficiently de-identified for research use. Exclusion Criteria: 1. Severely incomplete clinical information preventing preparation of a standardized case summary. 2. Non-rectal primary tumor. 3. Routine follow-up cases without a defined treatment decision question. 4. 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. 5. Cases containing sensitive information considered unsuitable for large language model input by the study team. 6. 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.

Trial Sites

Countries

China
View Registry Entry

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