Rectal CancerNCT07595107
Concordance Between Large Language Model and Multidisciplinary Team Recommendations in Rectal Cancer
An observational study of Rectal Cancer, run by Shandong Cancer Hospital and Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Large Language Model Recommendation Generation
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of consecutive adult patients with pathologically confirmed rectal adenocarcinoma who are scheduled for routine rectal cancer multidisciplinary team discussion at Shandong Cancer Hospital and Institute. Eligible cases must have sufficient clinical, pathological, and imaging information to allow preparation of a standardized de-identified case summary for concordance assessment between large language model-generated recommendations and multidisciplinary team reference recommendations.
Who may be able to join
- 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.
- Clinical data can be sufficiently de-identified for research use.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Radiation Oncology, Shandong Cancer Hospital and Institute
Jinan, Shandong, 0531
Jinbo Yue, doctor, 0531-67626442, jbyue@sdfmu.edu.cn
About this study
Official title: A Prospective Single-Center Observational Study Evaluating Concordance Between Large Language Model-Generated Recommendations and Multidisciplinary Team Recommendations in Rectal Cancer
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.
Read the detailed description
Management of rectal cancer often requires multidisciplinary decision-making based on tumor location, pelvic magnetic resonance imaging findings, clinical stage, mesorectal fascia or circumferential resection margin status, extramural vascular invasion, lateral lymph node status, metastatic status, previous treatment, surgical feasibility, organ preservation considerations, and patient preferences. Large language models have shown potential in medical information processing and clinical decision support, but their performance in complex oncologic decision-making has not been fully validated.
This study is designed as a prospective, single-center, observational concordance study. Consecutive patients with rectal adenocarcinoma who are scheduled for routine rectal cancer multidisciplinary team discussion at the study center will be screened. Before the multidisciplinary team meeting, investigators will prepare a standardized de-identified case summary using a predefined template. The summary will include relevant demographic information, clinical status, endoscopic findings, pathological and molecular information, key imaging findings, previous treatments, and patient preferences or practical constraints when available.
The same standardized case summary will be used as the input for a locally deployed large language model. A fixed prompt, fixed model version, and fixed inference parameters will be used throughout the study. Each case will be processed in an independent session, without additional interactive prompting or manual correction. The model will not use internet access, external knowledge retrieval, or retrieval-augmented generation during the study.
Routine multidisciplinary team discussion will proceed independently according to standard clinical workflow. The large language model output will not be provided to the multidisciplinary team and will not be used to guide patient treatment. Actual treatment decisions will be made by the treating physicians and multidisciplinary team according to routine clinical practice.
After both recommendations have been generated, the large language model recommendation and the multidisciplinary team recommendation will be transformed into a structured format. The structured recommendations will include the preferred treatment pathway, specific treatment plan, acceptable alternative options, key rationale, and need for additional examinations or information. De-identified and randomly ordered recommendations will then be evaluated using predefined concordance rules and blinded expert review.
The primary objective is to estimate the complete concordance rate between the large language model recommendation and the multidisciplinary team reference recommendation for the preferred treatment pathway. Secondary objectives include evaluation of concordance in specific treatment implementation, acceptable alternative options, identification of additional examinations or information needs, and the rate of major discordance. Exploratory analyses will assess patterns of major discordance and clinical features associated with concordant or discordant recommendations.
- Conditions
- Rectal Cancer
- Being tested
- Large Language Model Recommendation Generation
- Keywords
- Large Language Model, Multidisciplinary Team, Rectal Cancer, Clinical Decision Support, Artificial Intelligence
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Large Language Model Recommendation GenerationOther
For each enrolled case, a standardized de-identified clinical summary will be entered into a locally deployed large language model using a fixed prompt and fixed inference parameters. The model will generate a structured treatment recommendation for concordance assessment. The large language model output will not be disclosed to the multidisciplinary team and will not influence actual patient management.
| Study group | Role | What they receive |
|---|---|---|
| Rectal Cancer MDT Cases | 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. Receives: Other: Large Language Model Recommendation Generation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Cases With Complete Concordance in Preferred Treatment Pathway Assessed Using a Structured Concordance Adjudication Form
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.
Measured: From enrollment to completion of recommendation adjudication for each case, up to 12 months.
Secondary outcomes (5)
Percentage of Cases With Concordant Specific Treatment Implementation Assessed Using a Structured Concordance Adjudication Form
Percentage of cases in which the large language model recommendation and the multidisciplinary team reference recommendation are rated as concordant for the specific treatment implementation plan using a predefined structured concordance adjudication form and blinded expert review. The unit of measure is percentage of cases.
Measured: From enrollment to completion of recommendation adjudication for each case, up to 12 months.
Percentage of Applicable Cases With Concordant Alternative Treatment Options Assessed Using a Structured Concordance Adjudication Form
Percentage of applicable cases in which the large language model recommendation and the multidisciplinary team reference recommendation are rated as concordant regarding acceptable alternative treatment options using a predefined structured concordance adjudication form and blinded expert review. The unit of measure is percentage of applicable cases.
Measured: From enrollment to completion of recommendation adjudication for each case, up to 12 months.
Percentage of Cases With Concordant Identification of Additional Examination or Information Needs Assessed Using a Structured Concordance Adjudication Form
Percentage of cases in which the large language model recommendation and the multidisciplinary team reference recommendation agree on whether additional examinations, restaging, or key information are needed before treatment decision-making, as assessed using a predefined structured concordance adjudication form. The unit of measure is percentage of cases.
Measured: From enrollment to completion of recommendation adjudication for each case, up to 12 months.
Percentage of Cases With Major Discordance Assessed by Blinded Expert Review
Percentage of enrolled cases in which differences between the large language model recommendation and the multidisciplinary team reference recommendation are classified as major discordance using a predefined structured adjudication form and blinded expert review. Major discordance is defined as a clinically substantial difference potentially associated with undertreatment, overtreatment, incorrect treatment sequencing, inappropriate organ preservation or local control judgment, or omission of necessary additional evaluation. The unit of measure is percentage of cases.
Measured: From enrollment to completion of recommendation adjudication for each case, up to 12 months.
Cohen's Kappa Coefficient for Inter-Rater Agreement in Blinded Expert Assessment
Inter-rater agreement between independent blinded reviewers for judgment-based endpoints will be assessed using Cohen's kappa coefficient. Judgment-based endpoints include specific treatment implementation concordance, alternative treatment option concordance, major discordance classification, and failure mode classification when applicable. The unit of measure is the kappa coefficient.
Measured: At completion of blinded expert review, up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Jun 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinbo Yue, Shandong Cancer Hospital and Institute
- Investigators
- Jinbo Yue, MD, PhD, Principal investigator, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595107
- Sponsor's protocol ID
- LLM-MDT-RECTAL-001
- Status last verified
- Oct 2026
- First submitted
- 11 May 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-Center Observational Study Evaluating Concordance Between Large Language Model-Generated Recommendations and Multidisciplinary Team Recommendations in Rectal Cancer
- ClinicalTrials.gov ID
- NCT07595107
- Acronym / sponsor ID
- LLM-MDT-RECTAL-001
- Conditions
- Rectal Cancer
- Keywords
- Large Language Model, Multidisciplinary Team, Rectal Cancer, Clinical Decision Support, Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Management of rectal cancer often requires multidisciplinary decision-making based on tumor location, pelvic magnetic resonance imaging findings, clinical stage, mesorectal fascia or circumferential resection margin status, extramural vascular invasion, lateral lymph node status, metastatic status, previous treatment, surgical feasibility, organ preservation considerations, and patient preferences. Large language models have shown potential in medical information processing and clinical decision support, but their performance in complex oncologic decision-making has not been fully validated.
This study is designed as a prospective, single-center, observational concordance study. Consecutive patients with rectal adenocarcinoma who are scheduled for routine rectal cancer multidisciplinary team discussion at the study center will be screened. Before the multidisciplinary team meeting, investigators will prepare a standardized de-identified case summary using a predefined template. The summary will include relevant demographic information, clinical status, endoscopic findings, pathological and molecular information, key imaging findings, previous treatments, and patient preferences or practical constraints when available.
The same standardized case summary will be used as the input for a locally deployed large language model. A fixed prompt, fixed model version, and fixed inference parameters will be used throughout the study. Each case will be processed in an independent session, without additional interactive prompting or manual correction. The model will not use internet access, external knowledge retrieval, or retrieval-augmented generation during the study.
Routine multidisciplinary team discussion will proceed independently according to standard clinical workflow. The large language model output will not be provided to the multidisciplinary team and will not be used to guide patient treatment. Actual treatment decisions will be made by the treating physicians and multidisciplinary team according to routine clinical practice.
After both recommendations have been generated, the large language model recommendation and the multidisciplinary team recommendation will be transformed into a structured format. The structured recommendations will include the preferred treatment pathway, specific treatment plan, acceptable alternative options, key rationale, and need for additional examinations or information. De-identified and randomly ordered recommendations will then be evaluated using predefined concordance rules and blinded expert review.
The primary objective is to estimate the complete concordance rate between the large language model recommendation and the multidisciplinary team reference recommendation for the preferred treatment pathway. Secondary objectives include evaluation of concordance in specific treatment implementation, acceptable alternative options, identification of additional examinations or information needs, and the rate of major discordance. Exploratory analyses will assess patterns of major discordance and clinical features associated with concordant or discordant recommendations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rectal Cancer MDT Cases | – | Other: Large Language Model Recommendation GenerationAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of consecutive adult patients with pathologically confirmed rectal adenocarcinoma who are scheduled for routine rectal cancer multidisciplinary team discussion at Shandong Cancer Hospital and Institute. Eligible cases must have sufficient clinical, pathological, and imaging information to allow preparation of a standardized de-identified case summary for concordance assessment between large language model-generated recommendations and multidisciplinary team reference recommendations.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Large Language Model Recommendation GenerationFor each enrolled case, a standardized de-identified clinical summary will be entered into a locally deployed large language model using a fixed prompt and fixed inference parameters. The model will generate a structured treatment recommendation for concordance assessment. The large language model output will not be disclosed to the multidisciplinary team and will not influence actual patient management. | Other | Rectal Cancer MDT Cases |
Primary outcome
Percentage of Cases With Complete Concordance in Preferred Treatment Pathway Assessed Using a Structured Concordance Adjudication Form
Time frame: From enrollment to completion of recommendation adjudication for each case, up to 12 months.
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.
5 secondary outcomes
Percentage of Cases With Concordant Specific Treatment Implementation Assessed Using a Structured Concordance Adjudication Form
Time frame: From enrollment to completion of recommendation adjudication for each case, up to 12 months.
Percentage of Applicable Cases With Concordant Alternative Treatment Options Assessed Using a Structured Concordance Adjudication Form
Time frame: From enrollment to completion of recommendation adjudication for each case, up to 12 months.
Percentage of Cases With Concordant Identification of Additional Examination or Information Needs Assessed Using a Structured Concordance Adjudication Form
Time frame: From enrollment to completion of recommendation adjudication for each case, up to 12 months.
Percentage of Cases With Major Discordance Assessed by Blinded Expert Review
Time frame: From enrollment to completion of recommendation adjudication for each case, up to 12 months.
Cohen's Kappa Coefficient for Inter-Rater Agreement in Blinded Expert Assessment
Time frame: At completion of blinded expert review, up to 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jinbo Yue, MD, PhD principal investigator
Shandong Cancer Hospital and Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Shandong Cancer Hospital and Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinbo Yue, MD, PhD (053167626929, jbyue@sdfmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Cases With Complete Concordance in Preferred Treatment Pathway Assessed Using a Structured Concordance Adjudication Form (time frame: From enrollment to completion of recommendation adjudication for each case, up to 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.