Klinická aplikace ultrazvukové technologie s pomocí AI v předoperačním hodnocení rakoviny štítné žlázy
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
Typ studie
Typ studie
Zápis (Aktuální)
Zápis
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
Studijní kontakt
- Jméno: Bo Wang Professor
- Telefonní číslo: 13959123550
- E-mail: wangbo@fjmu.edu.cn
Studijní místa
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Fujian
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Fuzhou, Fujian, Čína, 350001
- Fujian Medical University Union Hospital
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Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Kritéria pro zařazení:
- Pacienti s předoperačním patologickým potvrzením zhoubných nádorů štítné žlázy podstupující chirurgickou léčbu.
- Pacienti s benigními tumory štítné žlázy, jako jsou adenomy štítné žlázy způsobující kompresivní příznaky, podstupující chirurgickou léčbu.
- Pacienti s kompletními a kvalitními tradičními dvourozměrnými barevnými ultrazvukovými snímky.
- Kompletní zprávy o pooperační patologii.
- Ochota zúčastnit se tohoto klinického hodnocení a podepsání informovaného souhlasu.
Kritéria vyloučení:
- Pacienti s anamnézou operace krku nebo radioterapie.
- Pacienti s anamnézou maligních nádorů v jiných částech těla.
- Pacienti s dysfunkcí štítné žlázy.
- Neúplné nebo nekvalitní tradiční dvourozměrné barevné ultrazvukové snímky.
- Neúplné zprávy o pooperační patologii.
- Odmítnutí účasti na této klinické studii.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
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Experimentální: AI-Assisted Preoperative Review
Participants undergo standard preoperative thyroid ultrasonography followed by a standardized AI-assisted repeat examination and surgeon-led review incorporating the locked AI system's thyroid-nodule output.
The AI system does not assess cervical lymph nodes.
All supplementary examinations and final diagnostic and surgical decisions are made by clinicians.
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After standard preoperative ultrasonography, the same participant underwent a standardized AI-assisted repeat examination.
The locked system identified and classified thyroid nodules and provided malignancy-score information for surgeon-led review.
It did not assess cervical lymph nodes and was not retrained or recalibrated during the study.
Additional fine-needle aspiration, intraoperative pathologic examination, and surgical management were determined by clinicians using the complete clinical assessment.
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Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Proportion of Participants Undergoing Supplementary Cytologic or Pathologic Examination
Časové okno: From completion of the AI-assisted repeat examination through completion of surgery
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Number and proportion of enrolled participants who underwent at least one additional cytologic or pathologic examination, such as fine-needle aspiration or intraoperative frozen-section examination, after completion of conventional ultrasonography and AI-assisted review and before completion of surgery.
Each participant is counted once regardless of the number of examinations.
The decision remained clinician led; cervical lymph-node examinations were outside the AI system's task.
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From completion of the AI-assisted repeat examination through completion of surgery
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Proportion of Participants With a Change in Planned Surgical Management
Časové okno: From completion of the AI-assisted review through surgery
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Number and proportion of enrolled participants with at least one documented change in the surgeon-led planned surgical approach or extent after conventional ultrasonography, AI-assisted review, and any supplementary pathological examination, when performed.
Changes may involve thyroid resection or cervical lymph-node management.
Each participant is counted once regardless of the number of changes.
The AI system provided thyroid-nodule information only and did not assess cervical lymph nodes.
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From completion of the AI-assisted review through surgery
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Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Distribution of C-TIRADS Categories Among Evaluated Thyroid Nodules
Časové okno: During standard preoperative ultrasonography, before the AI-assisted repeat examination
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Number and percentage of evaluated thyroid nodules in each clinician-assigned C-TIRADS category during conventional ultrasonography.
Nodule size, composition, echogenicity, margins, calcifications, and clinician-assessed cervical lymph-node findings were recorded as descriptive covariates and were not treated as separate outcome measures.
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During standard preoperative ultrasonography, before the AI-assisted repeat examination
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Proportion of Evaluated Thyroid Nodules Classified as AI-Positive
Časové okno: During the preoperative AI-assisted repeat examination, before surgery
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Number and percentage of evaluated thyroid nodules with a locked AI malignancy score >0.5.
The AI system evaluated thyroid nodules only and did not assess cervical lymph nodes.
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During the preoperative AI-assisted repeat examination, before surgery
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Results of Supplementary Cytologic or Pathologic Examinations
Časové okno: From supplementary sampling to availability of the corresponding result, before or during surgery
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Among participants who underwent at least one additional cytologic or pathologic examination, record the cytologic or histopathologic result for each sampled thyroid nodule or cervical lymph node.
Results are summarized at the examination level as nonmalignant, indeterminate, malignant, or metastatic, as applicable.
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From supplementary sampling to availability of the corresponding result, before or during surgery
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Final Histopathological Diagnosis of Resected Thyroid Nodules
Časové okno: From surgery until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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For each resected thyroid nodule linked unambiguously to the evaluated lesion, record the final diagnosis as benign, malignant, follicular tumor of uncertain malignant potential (FT-UMP), well-differentiated tumor of uncertain malignant potential (WDT-UMP), non-invasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP), or another borderline diagnosis.
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From surgery until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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Nodule-Level Sensitivity of AI and C-TIRADS
Časové okno: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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Using definitive postoperative histopathology as the reference standard, sensitivity is TP/(TP + FN), expressed as a percentage, for the locked AI classification (positive if score >0.5) and conventional C-TIRADS (positive if category 4a or higher).
Include only pathology-matched nodules with an unambiguous lesion-level link and a definitive benign or malignant diagnosis.
Exclude FT-UMP, WDT-UMP, NIFTP, other borderline diagnoses, and nodules without unambiguous lesion-level linkage.
These lesion-level exclusions do not alter the 515-participant workflow cohort.
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From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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Nodule-Level False-Negative Rate of AI and C-TIRADS
Časové okno: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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For each method, the false-negative rate is FN/(TP + FN), expressed as a percentage, among definitively malignant thyroid nodules.
AI positivity is defined as score >0.5; conventional ultrasound positivity is C-TIRADS category 4a or higher.
Include only pathology-matched nodules with an unambiguous lesion-level link and a definitive benign or malignant diagnosis.
Exclude FT-UMP, WDT-UMP, NIFTP, other borderline diagnoses, and nodules without unambiguous lesion-level linkage.
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From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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Nodule-Level Positive Predictive Value of AI and C-TIRADS
Časové okno: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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For each method, positive predictive value is TP/(TP + FP), expressed as a percentage, among thyroid nodules classified as positive.
AI positivity is defined as score >0.5; conventional ultrasound positivity is C-TIRADS category 4a or higher.
Include only pathology-matched nodules with an unambiguous lesion-level link and a definitive benign or malignant diagnosis.
Exclude FT-UMP, WDT-UMP, NIFTP, other borderline diagnoses, and nodules without unambiguous lesion-level linkage.
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From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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Nodule-Level Youden Index of AI and C-TIRADS
Časové okno: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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For each method, the Youden index is sensitivity + specificity - 1 using fixed binary thresholds.
AI positivity is defined as score >0.5; conventional ultrasound positivity is C-TIRADS category 4a or higher.
Include only pathology-matched nodules with an unambiguous lesion-level link and a definitive benign or malignant diagnosis.
Exclude FT-UMP, WDT-UMP, NIFTP, other borderline diagnoses, and nodules without unambiguous lesion-level linkage.
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From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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Distribution of Cervical Lymph-Node Metastasis Status Among Pathologically Examined Nodes
Časové okno: From surgery or supplementary sampling until the corresponding pathology result became available; assessed through October 15, 2025, over the approximately 14-month study period.
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Among cervical lymph nodes actually removed or sampled and pathologically examined, record the number and percentage with and without metastasis.
No pathologic reference diagnosis is assigned to unsampled lymph nodes.
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From surgery or supplementary sampling until the corresponding pathology result became available; assessed through October 15, 2025, over the approximately 14-month study period.
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Nodule-Level Specificity of AI and C-TIRADS
Časové okno: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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Using definitive postoperative histopathology as the reference standard, specificity is TN/(TN + FP), expressed as a percentage, for the locked AI classification (positive if score >0.5) and conventional C-TIRADS (positive if category 4a or higher).
Include only pathology-matched nodules with an unambiguous lesion-level link and a definitive benign or malignant diagnosis.
Exclude FT-UMP, WDT-UMP, NIFTP, other borderline diagnoses, and nodules without unambiguous lesion-level linkage.
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From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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Nodule-Level Negative Predictive Value of AI and C-TIRADS
Časové okno: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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Using definitive postoperative histopathology as the reference standard, negative predictive value is TN/(TN + FN), expressed as a percentage, for the locked AI classification (positive if score >0.5) and conventional C-TIRADS (positive if category 4a or higher).
Include only pathology-matched nodules with an unambiguous lesion-level link and a definitive benign or malignant diagnosis.
Exclude FT-UMP, WDT-UMP, NIFTP, other borderline diagnoses, and nodules without unambiguous lesion-level linkage.
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From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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Nodule-Level Accuracy of AI and C-TIRADS
Časové okno: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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Using definitive postoperative histopathology as the reference standard, accuracy is (TP + TN)/(TP + TN + FP + FN), expressed as a percentage, for the locked AI classification (positive if score >0.5) and conventional C-TIRADS (positive if category 4a or higher).
Include only pathology-matched nodules with an unambiguous lesion-level link and a definitive benign or malignant diagnosis.
Exclude FT-UMP, WDT-UMP, NIFTP, other borderline diagnoses, and nodules without unambiguous lesion-level linkage.
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From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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Area Under the ROC Curve for the Continuous AI Malignancy Score
Časové okno: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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Using definitive postoperative histopathology as the reference standard, calculate the area under the receiver operating characteristic curve for the continuous locked AI malignancy score.
Include only pathology-matched nodules with an unambiguous lesion-level link and a definitive benign or malignant diagnosis.
Exclude FT-UMP, WDT-UMP, NIFTP, other borderline diagnoses, and nodules without unambiguous lesion-level linkage.
No AUC is calculated for the single-threshold C-TIRADS classification.
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From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Aktuální)
Primární dokončení
Dokončení studie (Aktuální)
Dokončení studie
Termíny zápisu do studia
První předloženo
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První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
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Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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