- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07746830
Prospective Assessment of Alignment Between Multimodal Artificial Intelligence and Multidisciplinary Team Decisions in Gastrointestinal Oncology
31. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Studietype
Observasjonsmessig
Registrering (Antatt)
69
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Jing Sun, MD, PhD
- Telefonnummer: +86-13524284622
- E-post: sj11788@rjh.com.cn
Studiesteder
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-
Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200025
- Ruijin hospital Shanghai Jiaotong University, School of Medicine
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Ta kontakt med:
- Jing Sun, MD, PhD
- Telefonnummer: +86-13524284622
- E-post: sj11788@rjh.com.cn
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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.
|
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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Clinical Acceptability Concordance Rate Between the Multimodal Artificial Intelligence System and the Multidisciplinary Team
Tidsramme: At the predefined index clinical decision point, within 28 days after enrollment
|
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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Full Concordance Rate
Tidsramme: At the predefined index clinical decision point, within 28 days after enrollment
|
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
Tidsramme: At the predefined index clinical decision point, within 28 days after enrollment
|
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
|
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Successful AI Output Rate
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Distribution of AI-MDT Discordance Types
Tidsramme: At completion of independent expert evaluation, within 28 days after enrollment
|
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
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
5. august 2026
Primær fullføring (Antatt)
5. august 2027
Studiet fullført (Antatt)
5. august 2028
Datoer for studieregistrering
Først innsendt
31. juli 2026
Først innsendt som oppfylte QC-kriteriene
31. juli 2026
Først lagt ut (Faktiske)
5. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GI-ALIGN
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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