Набор по приглашению NCT07291362

AI-Assisted Pathologist Performance Improvement: A Multicenter, Prospective, Randomized Controlled Trial

Без фазы С лечением Pathology Foundation Model

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: AI pathology model, Control.
Кому может быть актуально: Состояния в реестре: Pathology Foundation Model. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Artificial Intelligence Model-Assisted Improvement of Pathologists' Performance in Clinical Diagnostic Tasks: A Multicenter, Prospective, Randomized Controlled Trial

Обзор

The investigators plan to conduct a multicenter, prospective, randomized controlled trial to systematically evaluate the added value of pathology-based AI models in the gastric cancer diagnostic workflow. The study will focus on comparing AI-assisted platform interpretation with conventional independent slide reading in terms of diagnostic accuracy (e.g., AUC), reading efficiency (e.g., comparison of time to diagnosis), quality of diagnostic reports, diagnostic confidence (Likert scale), and pathologists' satisfaction with the AI models. The investigators will also assess superiority for less-experienced (junior) pathologists and noninferiority for more-experienced (senior) pathologists. Successful completion of this project will provide high-level prospective evidence to support the standardized deployment, quality control, and broader application of pathology AI in the gastric cancer care pathway.

Вмешательства

Другое AI pathology model
Doctors in this group are required to use the AI pathology model to assist their diagnoses. The AI pathology model will provide a predicted result for each case.
Другое Control
Pathologists will independently diagnose each case based on their own clinical experience, and will record both their time to diagnosis and their diagnostic confidence.

Первичные конечные точки

Area under ROC curve (AUC) [Срок оценки: Assessments will be conducted within one week after the physicians' diagnoses.]

Вторичные конечные точки (4)

Diagnostic time per case [Срок оценки: Measured immediately after the physician's diagnosis.]
Diagnostic report quality score [Срок оценки: Within 1 week after the initial diagnosis for each case.]
Pathologists' diagnostic confidence [Срок оценки: At the time of diagnosis for each case.]
Pathologists' satisfaction with the AI pathology model [Срок оценки: Assessed once at the end of the AI-assisted reading period for each pathologist.]

Критерии участия

Критерии включения

Sex: ≥ 18 years of age;
Patients undergoing gastric mucosal biopsy or gastric cancer surgical resection, with available digital pathology images and clinical information.