Clinical trial · Observational
Concordance Between Large Language Model and Multidisciplinary Team Recommendations in Rectal Cancer
A Prospective Single-Center Observational Study Evaluating Concordance Between Large Language Model-Generated Recommendations and Multidisciplinary Team Recommendations in Rectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Large Language Model Recommendation Generation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Rectal Cancer MDT Cases
- description
- 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.
- interventionNames
- Other: Large Language Model Recommendation Generation
Primary outcomes (1)
- measure
- 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.
- description
- 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.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available