Prospective Assessment of Alignment Between Multimodal Artificial Intelligence and Multidisciplinary Team Decisions in Gastrointestinal Oncology

This prospective, single-center observational study will evaluate the concordance between a multimodal artificial intelligence system and multidisciplinary team decisions in patients with gastrointestinal tumors. For each enrolled case, the AI system and the MDT will independently review the same available clinical information, including medical history, laboratory findings, imaging, pathology, and other relevant diagnostic data, and will generate recommendations regarding diagnosis, staging, treatment planning, and further examinations. An independent expert panel will assess the agreement, clinical appropriateness, and potential major errors of the two decision pathways. AI-generated recommendations will be used solely for research evaluation and will not directly influence patient care. The study aims to determine the feasibility, reliability, and safety of multimodal AI-assisted decision-making in real-world gastrointestinal oncology workflows.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastric Cancer; Colorectal Cancer; Gastrointestinal Cancer
• Intervention / Treatment: Other: Multidisciplinary Team Clinical Decision Assessment; Other: Multimodal Artificial Intelligence-Based Clinical Decision Assessment

• Study Type: Observational
• Enrollment (Estimated): 69

Contacts and Locations

• Study Contact: Name: Jing Sun, MD, PhD; Phone Number: +86-13524284622; Email: sj11788@rjh.com.cn

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200025
      • Ruijin hospital Shanghai Jiaotong University, School of Medicine
      • Contact: Jing Sun, MD, PhD; Phone Number: +86-13524284622; Email: sj11788@rjh.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Consecutive adult patients with suspected or confirmed gastric, colon, or rectal cancer who are scheduled for multidisciplinary team evaluation at Ruijin Hospital because of a clinical question related to diagnosis, staging, perioperative treatment, surgical planning, recurrence or metastasis, conversion therapy, response assessment, or another complex management decision. Eligible participants must have an identifiable clinical decision time point and sufficient clinical information to permit paired evaluation by the multimodal artificial intelligence system and the multidisciplinary team.

Description

Inclusion Criteria:

1. Aged 18 years or older, with no restriction based on sex.
2. Histologically confirmed gastric, colon, or rectal cancer; or highly suspected gastric, colon, or rectal malignancy based on clinical, endoscopic, or imaging findings, with further diagnostic, staging, or treatment planning required.
3. Scheduled for multidisciplinary team evaluation at the study center because of an initial diagnosis, clinical staging, perioperative treatment, surgical planning, recurrence or metastasis, conversion therapy, treatment response assessment, or another complex clinical management question.
4. A clearly identifiable clinical decision time point can be established, and the clinical information available before that time point can be defined.
5. At the clinical decision time point, at least the basic medical history, the clinical question to be addressed, and at least one core source of information from endoscopy, pathology, or imaging are available. Completion of all examinations is not required, because missing examinations may be evaluated as part of diagnostic task planning.
6. A corresponding multidisciplinary team recommendation regarding diagnostic tasks or the principal treatment decision can be obtained for comparison with the artificial intelligence output.
7. Willing and able to understand the study and provide dated written informed consent.

Exclusion Criteria:

1. Further examination confirms a condition other than gastric, colon, or rectal cancer, and the case is not applicable to the gastrointestinal oncology pathways evaluated in this study.
2. The participant is undergoing routine follow-up or continuation of a previously established treatment plan and has no clinical question requiring additional diagnostic tasks, modification of the principal treatment pathway, or multidisciplinary team decision-making.
3. A clear clinical decision time point cannot be established, or information available before and after the decision cannot be distinguished, preventing comparison of the artificial intelligence system and the multidisciplinary team under the same information conditions.
4. Core clinical information is severely incomplete, such that the current stage of care and the clinical question cannot be identified and a clinically meaningful artificial intelligence output cannot be generated.
5. A clear multidisciplinary team recommendation corresponding to the clinical decision time point cannot be obtained, or the multidisciplinary team documentation is insufficient for paired evaluation.
6. The participant requires immediate resuscitation or urgent clinical management, and study recruitment could interfere with necessary medical care.
7. The participant is unable to provide valid informed consent because of impaired consciousness, severe cognitive impairment, or another reason, and no ethics-approved proxy consent procedure is available for this study.
8. The participant declines research use of the medical record, endoscopic, pathological, imaging, or other required clinical data.
9. Any other condition that, in the investigator's judgment, could seriously affect participant rights, data compliance, or the reliability of the study results.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients With Gastrointestinal Tumors; Participants with gastric, colon, or rectal tumors who are prospectively enrolled and undergo parallel, independent clinical decision assessments by a multimodal artificial intelligence system and a multidisciplinary team using the same clinical information available at the predefined decision time point. AI-generated recommendations are used solely for research evaluation and do not directly influence clinical care.

Other: Multidisciplinary Team Clinical Decision Assessment; Using the same clinical information available at the predefined decision time point, the institutional multidisciplinary team will independently formulate recommendations regarding diagnosis, staging, additional examinations, and treatment planning according to routine clinical practice. Clinical management will remain under the responsibility of the treating physicians and the multidisciplinary team. The MDT decision and the independently generated AI output will subsequently be compared and evaluated by an independent expert panel.; Other: Multimodal Artificial Intelligence-Based Clinical Decision Assessment; Available clinical information for each enrolled participant, including medical history, laboratory findings, endoscopic findings, imaging, pathology, and molecular testing results when available, will be entered into a multimodal artificial intelligence system. The system will independently generate a structured assessment of diagnosis, staging, additional diagnostic tasks, and treatment planning. The AI-generated output will be recorded solely for research comparison, will not be disclosed to the treating multidisciplinary team before its decision is finalized, and will not directly influence patient care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Acceptability Concordance Rate Between the Multimodal Artificial Intelligence System and the Multidisciplinary Team	The proportion of evaluable participants whose AI-generated diagnostic task plan and principal treatment recommendation are judged by an independent expert panel to be fully concordant with the MDT decision or a clinically acceptable alternative. Results will be reported as a percentage with a 95% confidence interval.	At the predefined index clinical decision point, within 28 days after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Full Concordance Rate	The proportion of evaluable participants whose AI-generated diagnostic task plan and principal treatment recommendation are judged to be fully concordant with the MDT decision.	At the predefined index clinical decision point, within 28 days after enrollment
Major Discordance Rate	The proportion of evaluable participants whose AI-generated recommendation is judged to contain a major discordance with potential for clinically significant harm.	At the predefined index clinical decision point, within 28 days after enrollment
Successful AI Output Rate	The proportion of enrolled participants for whom the AI system successfully generates an evaluable diagnostic task plan and principal treatment recommendation.	At the predefined index clinical decision point, within 28 days after enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of AI-MDT Discordance Types	The number and percentage of discordant cases classified by type, including diagnostic or staging errors, inappropriate additional testing, treatment selection errors, treatment sequencing errors, and potential safety risks.	At completion of independent expert evaluation, within 28 days after enrollment

Collaborators and Investigators

• Sponsor: Shanghai Minimally Invasive Surgery Center

Study record dates

Study Major Dates

• Study Start (Estimated): August 5, 2026
• Primary Completion (Estimated): August 5, 2027
• Study Completion (Estimated): August 5, 2028

Study Registration Dates

• First Submitted: July 31, 2026
• First Submitted That Met QC Criteria: July 31, 2026
• First Posted (Actual): August 5, 2026

Study Record Updates

• Last Update Posted (Actual): August 5, 2026
• Last Update Submitted That Met QC Criteria: July 31, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Gastric Cancer; Colorectal Cancer; Artificial Intelligence; MDT
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Stomach Neoplasms; Colorectal Neoplasms; Gastrointestinal Neoplasms
• Other Study ID Numbers: GI-ALIGN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is currently no plan to share individual participant data because the study involves sensitive clinical records, medical images, and digital pathology data with potential re-identification risks. Aggregate study results will be reported.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No