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Development of an AI-Agent for Urological Disease Diagnosis and Treatment

18 juli 2026 bijgewerkt door: Xu Kewei, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Development of an AI-Agent for Diagnosis and Treatment of Urological Diseases

Urological diseases such as urinary stones, prostate cancer, and bladder cancer are very common and often require highly specialized diagnosis and treatment. Today, the quality of care can vary between doctors, and there are not enough urology specialists to meet patient demand. Artificial intelligence (AI) may help doctors make faster and more consistent decisions.

This study aims to develop and test an AI-powered assistant called "UroAgent" that supports doctors in diagnosing and treating urological diseases. UroAgent is built on a large language model trained specifically for urology and is connected to tools that help it retrieve medical knowledge and analyze images. To build and test UroAgent, the research team will use 1,500 past patient records from 2010-2025 and collect 500 new patient cases for validation, for a total of 2,000 cases. This is an observational study: no patient's medical treatment will be changed because of it. The goal is to create a reliable AI tool that helps improve urological care for patients.

Studie Overzicht

Toestand

Werving

Conditie

Gedetailleerde beschrijving

This study protocol describes an observational study aiming to develop and validate UroAgent, an artificial-intelligence agent for the diagnosis and treatment of urological diseases. A total of 2,000 urological disease cases will be collected, comprising 1,500 retrospective cases recorded at the center between 2010 and 2025 for model development and 500 prospectively enrolled cases for independent performance validation. The primary evaluation is the concordance between UroAgent's diagnostic and treatment recommendations and the reference standards established by senior urologists, assessed through diagnostic accuracy, recommendation appropriateness, completeness, and safety; secondary evaluations include the agent's performance across disease subtypes (urinary stones, prostate cancer, bladder cancer) and its image-interpretation capability. All records will undergo de-identification, and the study will adhere to rigorous ethical standards and a pre-specified statistical analysis plan to provide robust evidence for the clinical application of this urology-specific AI agent.

Studietype

Observationeel

Inschrijving (Geschat)

2000

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Werving
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
        • Contact:
      • Shantou, Guangdong, China, 516600
        • Werving
        • Shenshan Medical Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
        • Contact:
    • Jiangxi
      • Ganzhou, Jiangxi, China, 341000
        • Werving
        • Ganzhou People's Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

The study population comprises patients diagnosed with urological diseases at Sun Yat-sen Memorial Hospital, including urinary stones, prostate cancer, bladder cancer, and other urological conditions. A total of 2,000 participants (cases) will be included: 1,500 retrospective cases with records from 2010 to 2025, and 500 prospective, consecutively enrolled cases. Both sexes are eligible, and the population is predominantly adult (the protocol does not specify an age cutoff; an age criterion of ≥18 years is recommended for registry entry, per the note in section 16). All included participants have complete clinical information, imaging data, and surgical video available for model development and validation. Records are de-identified prior to use. The population reflects the real-world case mix of a tertiary urology center.

Beschrijving

Inclusion Criteria:

  1. Diagnosed with a urological disease (e.g., urinary stones, prostate cancer, bladder cancer, and other urological conditions).
  2. Availability of complete clinical information, imaging data, and surgical video required for model development and validation.

Exclusion Criteria:

1. Missing clinical information, imaging data, or surgical video.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Urological Disease Cohort
The cohort consists of patients diagnosed with urological diseases-including urinary stones, prostate cancer, and bladder cancer-at Sun Yat-sen Memorial Hospital. A total of 2,000 cases are included: 1,500 retrospective cases recorded between 2010 and 2025 (used for model development) and 500 prospectively and consecutively enrolled cases (used for independent validation); all records are de-identified. The intervention (technology) of interest is "UroAgent," an artificial-intelligence diagnostic-and-treatment agent built on a urology-specialized large language model with integrated tool modules (knowledge retrieval, image interpretation). For each case, UroAgent's diagnostic and treatment recommendations are generated and compared with the analyses provided by human urology specialists, to evaluate the agent's performance-diagnostic accuracy, recommendation appropriateness, completeness, and safety-against expert judgment.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Diagnostic Accuracy of UroAgent
Tijdsspanne: Retrospective cases - at data extraction (single time point); Prospective cases - at enrollment (single time point); no longitudinal follow-up.
The primary outcome is UroAgent's diagnostic accuracy, measured as the F1 score of its leading diagnosis against the reference-standard final diagnosis. The reference standard is established by senior urologists from pathology, imaging, and clinical course. F1 = 2 × Precision × Recall / (Precision + Recall), computed per case and aggregated as macro-F1 across the 2,000-case cohort (1,500 retrospective + 500 prospective). Unit of measure: F1 score (range 0-1).
Retrospective cases - at data extraction (single time point); Prospective cases - at enrollment (single time point); no longitudinal follow-up.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Expert Subjective Accuracy Rating
Tijdsspanne: Retrospective cases - at data extraction (single time point); Prospective cases - at enrollment (single time point); no longitudinal follow-up.
Independent urologists rate the accuracy of UroAgent's diagnosis on a 5-point Likert scale (1 = completely inaccurate, 5 = completely accurate), blinded to model identity. Reported as the mean rating and the percentage of cases rated ≥ 4; disagreements resolved by a third urologist. Unit of measure: mean rating (1-5) and percentage of cases rated accurate (%).
Retrospective cases - at data extraction (single time point); Prospective cases - at enrollment (single time point); no longitudinal follow-up.
Treatment Recommendation Appropriateness of UroAgent
Tijdsspanne: Retrospective cases - at data extraction (single time point); Prospective cases - at enrollment (single time point); no longitudinal follow-up.
The proportion of cases in which UroAgent's management recommendation is rated appropriate. Two independent urologists rate each recommendation on a 5-point Likert appropriateness scale (1 = completely inappropriate, 5 = completely appropriate), blinded; "appropriate" defined as Likert ≥ 4; disagreement resolved by a third urologist. Unit of measure: percentage of cases (%) rated appropriate.
Retrospective cases - at data extraction (single time point); Prospective cases - at enrollment (single time point); no longitudinal follow-up.
Clinical Safety of UroAgent Recommendations
Tijdsspanne: Retrospective cases - at data extraction (single time point); Prospective cases - at enrollment (single time point); no longitudinal follow-up.
The rate of clinically unsafe recommendations. Each case is reviewed by senior urologists using a safety rubric and flagged (binary per case) for any contraindicated, erroneous, or potentially harmful recommendation. Unit of measure: percentage of cases (%) with ≥ 1 unsafe recommendation.
Retrospective cases - at data extraction (single time point); Prospective cases - at enrollment (single time point); no longitudinal follow-up.
Concordance and Non-Inferiority of UroAgent versus Clinician Diagnoses
Tijdsspanne: Retrospective cases - at data extraction (single time point); Prospective cases - at enrollment (single time point); no longitudinal follow-up.
On the same cases, UroAgent's diagnoses are compared with those of practicing urologists. Reported as the agreement rate (%) between UroAgent and clinician diagnoses, plus the diagnostic-accuracy difference in percentage points (pp); Cohen's κ reported as a supplementary statistic. Both are assessed against the reference-standard final diagnosis. Unit of measure: agreement rate (%) and accuracy difference (pp).
Retrospective cases - at data extraction (single time point); Prospective cases - at enrollment (single time point); no longitudinal follow-up.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Medewerkers

Shenshan Medical Center, Memorial Hospital of Sun Yat-sen University
Ganzhou City People's Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 april 2025

Primaire voltooiing (Geschat)

31 december 2026

Studie voltooiing (Geschat)

30 juni 2027

Studieregistratiedata

Eerst ingediend

12 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

18 juli 2026

Eerst geplaatst (Werkelijk)

23 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

23 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

18 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • SYSKY-2025-151-03

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual participant data (IPD) will not be shared. This single-center observational study uses de-identified clinical records, imaging, and surgical video. The retrospective cases (2010-2025) were not collected with consent for external data sharing, and applicable personal-information protection regulations (e.g., China's Personal Information Protection Law) together with institutional policy prohibit transfer of patient-level data outside the sponsoring hospital. The study's primary deliverable is the UroAgent model and aggregated performance results, which will be disseminated through peer-reviewed publications and the trial registry record. Collaboration requests will be considered case-by-case under institutional approval.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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