Concordance Between Large Language Model and Multidisciplinary Team Recommendations in Rectal Cancer (NCT07595107) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Concordance Between Large Language Model and Multidisciplinary Team Recommendations in Rectal Cancer
China180 participantsStarted 2026-06-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Cases With Complete Concordance in Preferred Treatment Pathway Assessed Using a Structured Concordance Adjudication Form
Timeframe: From enrollment to completion of recommendation adjudication for each case, up to 12 months.
. Clinical data can be sufficiently de-identified for research use.
Exclusion criteria
. 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.