- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07746830
Prospective Assessment of Alignment Between Multimodal Artificial Intelligence and Multidisciplinary Team Decisions in Gastrointestinal Oncology
31 luglio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Tipo di studio
Osservativo
Iscrizione (Stimato)
69
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Jing Sun, MD, PhD
- Numero di telefono: +86-13524284622
- Email: sj11788@rjh.com.cn
Luoghi di studio
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Cina, 200025
- Ruijin hospital Shanghai Jiaotong University, School of Medicine
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Contatto:
- Jing Sun, MD, PhD
- Numero di telefono: +86-13524284622
- Email: sj11788@rjh.com.cn
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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.
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Clinical Acceptability Concordance Rate Between the Multimodal Artificial Intelligence System and the Multidisciplinary Team
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Full Concordance Rate
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Distribution of AI-MDT Discordance Types
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
5 agosto 2026
Completamento primario (Stimato)
5 agosto 2027
Completamento dello studio (Stimato)
5 agosto 2028
Date di iscrizione allo studio
Primo inviato
31 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
31 luglio 2026
Primo Inserito (Effettivo)
5 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
5 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
31 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- GI-ALIGN
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano 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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .