NCT07595107 Concordance Between Large Language Model and Multidisciplinary Team Recommendations in Rectal Cancer
| NCT ID | NCT07595107 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shandong Cancer Hospital and Institute |
| Condition | Rectal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 180 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 180 participants in total. It began in 2026-06-01 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Jinbo Yue, MD, PhD
PRINCIPAL INVESTIGATOR
Shandong Cancer Hospital and Institute
Frequently Asked Questions
Who can join the NCT07595107 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07595107 currently recruiting?
Yes, NCT07595107 is actively recruiting participants. Contact the research team at jbyue@sdfmu.edu.cn for enrollment information.
Where is the NCT07595107 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT07595107 clinical trial?
NCT07595107 is sponsored by Shandong Cancer Hospital and Institute. The principal investigator is Jinbo Yue, MD, PhD at Shandong Cancer Hospital and Institute. The trial plans to enroll 180 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.