- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07746830
Prospective Assessment of Alignment Between Multimodal Artificial Intelligence and Multidisciplinary Team Decisions in Gastrointestinal Oncology
31 de julio de 2026 actualizado por: Sun Jin, Shanghai Minimally Invasive Surgery Center
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Tipo de estudio
De observación
Inscripción (Estimado)
69
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Jing Sun, MD, PhD
- Número de teléfono: +86-13524284622
- Correo electrónico: sj11788@rjh.com.cn
Ubicaciones de estudio
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200025
- Ruijin hospital Shanghai Jiaotong University, School of Medicine
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Contacto:
- Jing Sun, MD, PhD
- Número de teléfono: +86-13524284622
- Correo electrónico: sj11788@rjh.com.cn
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
Inclusion Criteria:
- Aged 18 years or older, with no restriction based on sex.
- 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.
- 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.
- A clearly identifiable clinical decision time point can be established, and the clinical information available before that time point can be defined.
- 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.
- A corresponding multidisciplinary team recommendation regarding diagnostic tasks or the principal treatment decision can be obtained for comparison with the artificial intelligence output.
- Willing and able to understand the study and provide dated written informed consent.
Exclusion Criteria:
- 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.
- 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.
- 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.
- 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.
- 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.
- The participant requires immediate resuscitation or urgent clinical management, and study recruitment could interfere with necessary medical care.
- 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.
- The participant declines research use of the medical record, endoscopic, pathological, imaging, or other required clinical data.
- Any other condition that, in the investigator's judgment, could seriously affect participant rights, data compliance, or the reliability of the study results.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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.
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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.
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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Clinical Acceptability Concordance Rate Between the Multimodal Artificial Intelligence System and the Multidisciplinary Team
Periodo de tiempo: At the predefined index clinical decision point, within 28 days after enrollment
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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.
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At the predefined index clinical decision point, within 28 days after enrollment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Full Concordance Rate
Periodo de tiempo: At the predefined index clinical decision point, within 28 days after enrollment
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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.
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At the predefined index clinical decision point, within 28 days after enrollment
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Major Discordance Rate
Periodo de tiempo: At the predefined index clinical decision point, within 28 days after enrollment
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The proportion of evaluable participants whose AI-generated recommendation is judged to contain a major discordance with potential for clinically significant harm.
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At the predefined index clinical decision point, within 28 days after enrollment
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Successful AI Output Rate
Periodo de tiempo: At the predefined index clinical decision point, within 28 days after enrollment
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The proportion of enrolled participants for whom the AI system successfully generates an evaluable diagnostic task plan and principal treatment recommendation.
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At the predefined index clinical decision point, within 28 days after enrollment
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Distribution of AI-MDT Discordance Types
Periodo de tiempo: At completion of independent expert evaluation, within 28 days after enrollment
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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.
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At completion of independent expert evaluation, within 28 days after enrollment
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
5 de agosto de 2026
Finalización primaria (Estimado)
5 de agosto de 2027
Finalización del estudio (Estimado)
5 de agosto de 2028
Fechas de registro del estudio
Enviado por primera vez
31 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
31 de julio de 2026
Publicado por primera vez (Actual)
5 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
31 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Enfermedades intestinales
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Enfermedades del Estómago
- Neoplasias Intestinales
- Enfermedades Rectales
- Enfermedades del Colon
- Neoplasias de Estómago
- Neoplasias colorrectales
- Neoplasias Gastrointestinales
Otros números de identificación del estudio
- GI-ALIGN
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .