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Идёт набор NCT06463392

Deep Learning-based sbORN Diagnostic Model

— Наблюдательное Nasopharyngeal Carcinoma Herpesvirus 4, Human

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: No Intervention: Observational Cohort.
Кому может быть актуально
Состояния в реестре: Nasopharyngeal Carcinoma, Herpesvirus 4, Human. 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

Development of Deep-Learning-Based Multimodal Post Radiotherapy Skull-Base Osteonecrosis and Recurrence of Nasopharyngeal Carcinoma Differential Diagnostic Model

Обзор

Skull-base osteonecrosis (sbORN) is a severe long-term complication of nasopharyngeal carcinoma (NPC) post radiotherapy, which significantly diminish the quality of life, increase the risk of internal carotid artery rupture, and is frequently misdiagnosed as NPC recurrence. Novel diagnostic tools are therefore clinically significant. In this study, the investigators seek to ask if a deep-learning-based model shows a significantly higher sensitivity than radiologists. With a cross-sectional design, the investigators aim to recruit 312 participants in Sun Yat-sen Memorial Hospital, Guangzhou, China that meet the eligibility criteria.

Вмешательства

  • Другое No Intervention: Observational Cohort
    No intervention is scheduled for this observational study.

Первичные конечные точки

  • Area under curve of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model. [Срок оценки: Baseline]
  • Area under curve of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists. [Срок оценки: Baseline]
Вторичные конечные точки (12)
  • Sensitivity of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model. [Срок оценки: Baseline]
  • Specificity of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model. [Срок оценки: Baseline]
  • F1 score of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model. [Срок оценки: Baseline]
  • Positive predictive value of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model. [Срок оценки: Baseline]
  • Negative predictive value of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model. [Срок оценки: Baseline]
  • Sensitivity of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists. [Срок оценки: Baseline]
  • Specificity of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists. [Срок оценки: Baseline]
  • F1 score of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists. [Срок оценки: Baseline]
  • Positive predictive value of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists. [Срок оценки: Baseline]
  • Negative predictive value of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists. [Срок оценки: Baseline]
  • Dice similarity coefficient of the MRI contouring between the deep-learning-based multimodal model and the radiologists. [Срок оценки: Baseline]
  • Average surface distance of the MRI contouring between the deep-learning-based multimodal model and the radiologists. [Срок оценки: Baseline]

Критерии участия

Критерии включения

  • Equal to or older than 18 years old.
  • A history of histologically confirmed nonkeratinizing undifferentiated nasopharyngeal carcinoma.
  • A history of radical radiotherapy at nasopharynx.
  • Complete remission six months post radical radiotherapy according to RECIST 1.1.
  • No evidence of distant metastasis upon recruitment.
  • Diagnosis of sbORN given by senior radiologist with 2-4 Likert scores.
  • Consent to biopsy awake or under general anesthesia.
  • Consent to perform blood tests, EBV DNA, EBV IgAs, and MRI inspection of nasopharynx and neck.
  • With a written consent.

Критерии исключения

  • MRI artifacts or other factors that interfere radiological diagnosis and region of interest contouring.
  • Suspected lesion is not confined to nasopharynx and skull-base.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Китай · 1 центр
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University — Гуанчжоу

Идентификаторы

NCT: NCT06463392 · SYSKY-2024-395-03

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗