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

Sponsor
Shanghai Minimally Invasive Surgery Center
Study ID
NCT07746830
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Multidisciplinary Team Clinical Decision Assessment — OTHER
    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.
  • Multimodal Artificial Intelligence-Based Clinical Decision Assessment — OTHER
    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.

Study Details

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.

Key Dates

First listed
Aug 5, 2026
Start date
Aug 5, 2026
Status verified
Jul 2026
Primary completion
Aug 5, 2027
Completion
Aug 5, 2028

Study Design

Enrollment
69 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Clinical Acceptability Concordance Rate Between the Multimodal Artificial Intelligence System and the Multidisciplinary Team [ Time Frame: At the predefined index clinical decision point, within 28 days after enrollment ]

Central Contacts

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