Concordance between a Large Language Model and a Multidisciplinary Team for Rectal Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center observational study involving adults with pathologically confirmed rectal adenocarcinoma who are scheduled for a standard multidisciplinary team discussion. For each case, a de-identified clinical summary is prepared and used both by the local large language model and by the actual MDT, with the LLM’s recommendation kept hidden from clinicians. Concordance will be measured using predefined rules and blinded expert review. The study aims to assess the potential role of AI-based decision support in complex rectal cancer management. Management considerations include tumor location, MRI findings, staging, margins, invasion, nodal status, prior treatments, feasibility of surgery, organ preservation, and patient preferences.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Radiation Oncology, Shandong Cancer Hospital and Institute
  Jinan, Shandong, China Recruiting

Study contacts

• Principal investigator: Jinbo Yue, MD, PhD — Shandong Cancer Hospital and Institute
• Study coordinator: Jinbo Yue, MD, PhD
• Email: jbyue@sdfmu.edu.cn
• Phone: 053167626929

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.